1053 AURICAL FREEFIT
Report
- Report Number
- 9612197-2020-00004
- Event Type
- Malfunction
- Date Received
- February 21, 2020
- Date of Event
- February 5, 2020
- Report Date
- February 11, 2020
- Manufacturer
- NATUS MEDICAL DENMARK
- Product Code
- ETW
- PMA / PMN Number
- K110286
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- GM
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
Narratives
UPDATE 13MAY 2020. CAPA004611 HAD BEEN INITIATED TO INVESTIGATE BATTERY MELTING ISSUE. CORRECTIVE ACTION PLAN: CA 1: USER GUIDE (7-50-1220-XX) UPDATE INCLUDING TRANSLATIONS. MAINTENANCE TO INCLUDE ANNUAL BATTERY EXCHANGE. ( DUE OCT. 1, 2020). CA 2: SERVICE MANUAL (7-50-1050-EN) UPDATE. MAINTENANCE TO INCLUDE ANNUAL BATTERY EXCHANGE. (DUE AUG. 1, 2020). CA 3: REFERENCE MANUAL (7-50-0930-EN) UPDATE. MAINTENANCE TO INCLUDE ANNUAL BATTERY EXCHANGE. (DUE AUG. 1, 2020). CA 4: CHANGE BATTERY (8-73-02200 WHERE USED IN 1053 BOMS). (DUE DEC. 1, 2020). CA 5: SERVICE SPEC. (0-80-00311) UPDATE. GENERAL REVIEW, TEMPLATE AND BATTERY EXCHANGE (DUE DEC. 1, 2020). CA 6: CREATE NEW SERVICE NOTE INCLUDING IMPLEMENTATION. ANNUAL BATTERY EXCHANGE (DUE JUL. 1, 2020). ALL CORRECTIVE ACTIONS CAN BE COMPLETED INDEPENDENTLY.
06 JAN 2020 (FOLLOW UP 011) (COMPLAINT#: (B)(4). CONCLUSION ON ROOT CAUSE OF THIS EVENT IS RELATED TO STRESS PLACED ON THE BATTERY CAUSED BY REPEATEDLY OVERCHARGING DUE TO CHARGING PROCEDURES CONTROLLED BY IMPLEMENTED FIRMWARE IN COMBINATION WITH ACTUAL USE SCENARIO. CAPA004611 WAS GENERATED TO INVESTIGATE THIS ISSUE. CORRECTIVE ACTION PLAN FOR CAPA004611: CA 1: USER GUIDE (7-50-1220-XX) UPDATED - INCLUDING TRANSLATIONS. MAINTENANCE TO INCLUDE ANNUAL BATTERY EXCHANGE. CA 2: SERVICE MANUAL (7-50-1050-EN) UPDATED. MAINTENANCE TO INCLUDE ANNUAL BATTERY EXCHANGE. CA 3: REFERENCE MANUAL (7-50-0930-EN) UPDATED. MAINTENANCE TO INCLUDE ANNUAL BATTERY EXCHANGE. CA 4: CHANGED BATTERY (8-73-02200 WHERE USED IN 1053 BILL OF MATERIALS). CA 5: SERVICE SPECIFICATION. (0-80-00311) UPDATED. GENERAL REVIEW, TEMPLATE AND BATTERY EXCHANGE. CA 6: CREATED NEW SERVICE NOTE INCLUDING IMPLEMENTATION. ANNUAL BATTERY EXCHANGE. FINAL STATUS OF CAPA004611: CA1: -PROTO VERSION OF IFU RELEASED. TRANSLATIONS COMPLETED. CA2: -PROTO VERSION OF IFU RELEASED. TRANSLATIONS COMPLETED. CA3: -PROTO VERSION OF IFU RELEASED. TRANSLATIONS COMPLETED. CA4: COMPLETED AS FOLLOWS: NEW BATTERY IDENTIFIED AND RELEASED. DOC-048835 - 1053 FREEFIT BATTERY CHANGE - DESIGN PLANNING CHECKLIST RELEASED. DOC-048834 - 1053 FREEFIT BATTERY CHANGE - TECHNICAL DESIGN REVIEW RECORD RELEASED. VERIFICATION PLAN AND PROTOCOL ARE RELEASED. VERIFICATION REPORT IS RELEASED. RII FOR BATTERY IS RELEASED . BOM CHANGES ARE RELEASED. DMR UPDATES ARE RELEASED. CA5: COMPLETED WITH THIS RATIONALE: "TASK IS NOT APPLICABLE. DOCUMENT IS REVIEWED AND IT IS CONCLUDED THAT ITS CONTENT IS NOT ACTUAL ANYMORE AND DOES NOT NEED TO BE UPDATED. PURPOSE OF DOCUMENT WAS ORIGINALLY INTENDED AS AN PRE-INPUT FOR CREATING INITIAL REVISION OF THE SERVICE MANUAL. SERVICE MANUAL UPDATE IS CAPTURED UNDER CA2". CA6: QMS-005706 - FS - SERVICE NOTE 20-01 ANNUAL 1053 AURICAL PMM BATTERY REPLACEMENT WORK INSTRUCTION RELEASED. (INCLUDING ELEAP TRAINING SET UP). EFFECTIVITY CHECK PLAN WILL BE CARRIED OUT ON CAPA006611 AS FOLLOWS: CONTINUE COMPLAINT TRENDING ON QUARTERLY BASIS ON THE ISSUE (MELTING PLASTIC IN BATTERY COMPARTMENT) FOR ONE YEAR FROM IMPLEMENTATION OF ACTIONS. NEW BATTERY IS PART NO: 031814 (PANASONIC: BK200AAB). ACCEPTANCE CRITERIA: 1 COMPLAINT INVOLVING THE NEW BATTERY. FAIL CRITERIA: 0 COMPLAINT INVOLVING THE NEW BATTERY. RISK WAS ASSESSED AS MINOR (3) AND PRODUCT RISK IS CONSIDERED TOLERABLE, AS PER QMS-001647 RISK MANAGEMENT INSTRUCTION FOR THE POTENTIAL HAZARD OF MINOR USER BURN, AND DELAYED PATIENT DIAGNOSIS IF EQUIPMENT BECOMES NON-FUNCTIONAL. THE BENEFIT OF THE DEVICE OUTWEIGHS THE MINOR RISK REMAINING.
UPDATE 27 NOV 2020 (FOLLOW UP 010) (COMPLAINT#: (B)(4). CAPA004611 WAS GENERATED TO INVESTIGATE THIS ISSUE. CONCLUSION ON ROOT CAUSE IS RELATED TO STRESS PLACED ON THE BATTERY CAUSED BY REPEATEDLY OVERCHARGING DUE TO CHARGING PROCEDURES CONTROLLED BY IMPLEMENTED FIRMWARE IN COMBINATION WITH ACTUAL USE SCENARIO. CAPA ACTIONS ARE STILL ONGOING AS BELOW, AND OVERALL STATUS OF THESE ACTIONS ARE ON TRACK. CORRECTIVE ACTION PLAN CAPA004611: CA 1: USER GUIDE (7-50-1220-XX) UPDATE - INCLUDING TRANSLATIONS. MAINTENANCE TO INCLUDE ANNUAL BATTERY EXCHANGE. ( DUE OCT. 1, 2020). CA 2: SERVICE MANUAL (7-50-1050-EN) UPDATE. MAINTENANCE TO INCLUDE ANNUAL BATTERY EXCHANGE. (DUE AUG. 1, 2020). CA 3: REFERENCE MANUAL (7-50-0930-EN) UPDATE. MAINTENANCE TO INCLUDE ANNUAL BATTERY EXCHANGE. (DUE AUG. 1, 2020). CA 4: CHANGE BATTERY (8-73-02200 WHERE USED IN 1053 BOMS). (DUE DEC. 1, 2020). CA 5: SERVICE SPEC. (0-80-00311) UPDATE. GENERAL REVIEW, TEMPLATE AND BATTERY EXCHANGE (DUE DEC. 1, 2020). CA 6: CREATE NEW SERVICE NOTE INCLUDING IMPLEMENTATION. ANNUAL BATTERY EXCHANGE (DUE JUL. 1, 2020). ALL CORRECTIVE ACTIONS CAN BE COMPLETED INDEPENDENTLY. CA1: -PROTO VERSION OF IFU RELEASED WITH ECO#: 34938. TRANSLATIONS COMPLETED. FINAL ECO#: 35568 IS SUBMITTED. CA2: -PROTO VERSION OF IFU RELEASED WITH ECO#: 34938. FINAL ECO#: 35568 IS SUBMITTED. CA3: -PROTO VERSION OF IFU RELEASED WITH ECO#: 34938. FINAL ECO#: 35568 IS SUBMITTED. CA4: NEW BATTERY IDENTIFIED. ECR#: 18858 IS RELEASED. DCP DOC-048835 RELEASED. TECH. DESIGN REVIEW DOC-048834 RELEASED. VERIFICATION PLAN AND PROTOCOL ARE RELEASED. VERIFICATION REPORT IS RELEASED WITH DCO#: 45578. BATTERY IS RELEASED WITH ECO#: 35633. RII FOR BATTERY IS SUBMITTED WITH DCO#: 40855. BOM CHANGES ARE PREPARED WITH ECO#: 34922 (AWAITING BATTERY DELIVERY CONFIRMATION). DMR UPDATES ARE PREPARED WITH DCO#: 45744 (AWAITING BATTERY DELIVERY CONFIRMATION). CA5: COMPLETED WITH THIS RATIONALE: "TASK IS NOT APPLICABLE. DOCUMENT IS REVIEWED AND IT IS CONCLUDED THAT ITS CONTENT IS NOT ACTUAL ANYMORE AND DOES NOT NEED TO BE UPDATED. PURPOSE OF DOCUMENT WAS ORIGINALLY INTENDED AS AN PRE-INPUT FOR CREATING INITIAL REVISION OF THE SERVICE MANUAL. SERVICE MANUAL UPDATE IS CAPTURED UNDER CA2". CA6: QMS-005706 IS RELEASED. ELEAP TRAINING IS PREPARED AND READY FOR SUBMISSION. OTHER ACTIONS TAKEN: WEEKLY FOLLOW-UP MEETINGS SCHEDULED. REVIEW OF ADDITIONAL RECEIVED COMPLAINTS HAS BEEN COMPLETED. SEVERITY, PROBABILITY AND RISK LEVEL REMAINS UNCHANGED. THERE IS NO NEED FOR UPDATING RISK ASSESSMENT. EFFECTIVITY CHECK TO BE COMPLETED ON CAPA004611 ONCE THE CAPA ACTIONS ARE IMPLEMENTED.
UPDATE (B)(6)2020 FOLLOW UP 006. COMPLAINT#1(B)(4). INVESTIGATION AND FINDINGS THE STATUS OF CAPA004611 IS CURRENTLY AT IMPLEMENTING ACTIONS AND IS ON TRACK. CORRECTIVE ACTION PLAN CAPA004611 CA 1: USER GUIDE (7-50-1220-XX) UPDATE - INCLUDING TRANSLATIONS. MAINTENANCE TO INCLUDE ANNUAL BATTERY EXCHANGE. (B)(6)2020 CA 2: SERVICE MANUAL (7-50-1050-EN) UPDATE. MAINTENANCE TO INCLUDE ANNUAL BATTERY EXCHANGE.(B)(6)2020 CA 3: REFERENCE MANUAL (7-50-0930-EN) UPDATE. MAINTENANCE TO INCLUDE ANNUAL BATTERY EXCHANGE. (DUE AUG. 1, 2020). CA 4: CHANGE BATTERY (8-73-02200 WHERE USED IN 1053 BOMS). (B)(6)2020 CA 5: SERVICE SPEC. (0-80-00311) UPDATE. GENERAL REVIEW, TEMPLATE AND BATTERY EXCHANGE (B)(6)2020 CA 6: CREATE NEW SERVICE NOTE INCLUDING IMPLEMENTATION. ANNUAL BATTERY EXCHANGE (B)(6)2020 ALL CORRECTIVE ACTIONS CAN BE COMPLETED INDEPENDENTLY. OVERALL STATUS: ON TRACK. CA1: DRAFT CURRENTLY BEING REVIEWED. CA2: INITIATED. CA3: DRAFT CURRENTLY BEING REVIEWED. CA4: NEW BATTERY IDENTIFIED. DISCUSSING REQUIRED RESOURCES AND APPROACH WITH SUSTAINING TEAM. CA5: COMPLETED WITH RATIONALE. DOCUMENT IS REVIEWED AND IT IS CONCLUDED THAT ITS CONTENT IS NOT ACTUAL ANYMORE AND DOES NOT NEED TO BE UPDATED. PURPOSE OF DOCUMENT WAS ORIGINALLY INTENDED AS AN PRE-INPUT FOR CREATING INITIAL REVISION OF THE SERVICE MANUAL. SERVICE MANUAL UPDATE IS CAPTURED UNDER CA2. CA6: QMS-005706 RELEASED WITH DCO#40712. ELEAP TRAINING IS PREPARED AND READY FOR SUBMISSION. EFFECTIVITY CHECK TO BE COMPLETED ON CAPA004611 ONCE THE CAPA ACTIONS ARE IMPLEMENTED.
UPDATE 11JUNE 2020 (FOLLOW UP 004) (COMPLAINT# (B)(4). THE STATUS OF CAPA004611 IS CURRENTLY AT IMPLEMENTING ACTIONS AND IS ON TRACK. CORRECTIVE ACTION PLAN CAPA004611. CA 1: USER GUIDE (7-50-1220-XX) UPDATE - INCLUDING TRANSLATIONS. MAINTENANCE TO INCLUDE ANNUAL BATTERY EXCHANGE. (DUE OCT. 1, 2020). CA 2: SERVICE MANUAL (7-50-1050-EN) UPDATE. MAINTENANCE TO INCLUDE ANNUAL BATTERY EXCHANGE. (DUE AUG. 1, 2020). CA 3: REFERENCE MANUAL (7-50-0930-EN) UPDATE. MAINTENANCE TO INCLUDE ANNUAL BATTERY EXCHANGE. (DUE AUG. 1, 2020). CA 4: CHANGE BATTERY (8-73-02200 WHERE USED IN 1053 BOMS). (DUE DEC. 1, 2020). CA 5: SERVICE SPEC. (0-80-00311) UPDATE. GENERAL REVIEW, TEMPLATE AND BATTERY EXCHANGE (DUE DEC. 1, 2020). CA 6: CREATE NEW SERVICE NOTE INCLUDING IMPLEMENTATION. ANNUAL BATTERY EXCHANGE (DUE JUL. 1, 2020). ALL CORRECTIVE ACTIONS CAN BE COMPLETED INDEPENDENTLY. EFFECTIVITY CHECK TO BE COMPLETED ON CAPA004611 ONCE THE CAPA ACTIONS ARE IMPLEMENTED.
UPDATE 29 OCT 2020 (FOLLOW UP 009) (COMPLAINT#: (B)(4). THE STATUS OF CAPA: 004611 IS CURRENTLY AT IMPLEMENTING ACTIONS AND IS ON TRACK. CORRECTIVE ACTION PLAN CAPA: 004611. CA 1: USER GUIDE (7-50-1220-XX) UPDATE - INCLUDING TRANSLATIONS. MAINTENANCE TO INCLUDE ANNUAL BATTERY EXCHANGE. ( DUE OCT. 1, 2020). CA 2: SERVICE MANUAL (7-50-1050-EN) UPDATE. MAINTENANCE TO INCLUDE ANNUAL BATTERY EXCHANGE. (DUE AUG. 1, 2020). CA 3: REFERENCE MANUAL (7-50-0930-EN) UPDATE. MAINTENANCE TO INCLUDE ANNUAL BATTERY EXCHANGE. (DUE AUG. 1, 2020). CA 4: CHANGE BATTERY (8-73-02200 WHERE USED IN 1053 BOMS). (DUE DEC. 1, 2020). CA 5: SERVICE SPEC. (0-80-00311) UPDATE. GENERAL REVIEW, TEMPLATE AND BATTERY EXCHANGE (DUE DEC. 1, 2020). CA 6: CREATE NEW SERVICE NOTE INCLUDING IMPLEMENTATION. ANNUAL BATTERY EXCHANGE (DUE JUL. 1, 2020). ALL CORRECTIVE ACTIONS CAN BE COMPLETED INDEPENDENTLY. CA1: PROTO VERSION OF IFU RELEASED. CA2: PROTO VERSION OF IFU RELEASED. CA3: PROTO VERSION OF IFU RELEASED. CA4: NEW BATTERY IDENTIFIED. ECR#: 18858 IS RELEASED. DCP DOC-048835 RELEASED. BOM CHANGES PREPARED WITH ECO#: 34922. TECH. DESIGN REVIEW DOC-048834 RELEASED. VERIFICATION PLAN AND PROTOCOL ARE RELEASED. VERIFICATION IS STARTED. ESTIMATED COMPLETION IS WEEK 02 NOV 2020. CA5: COMPLETED WITH THIS RATIONALE: "TASK IS NOT APPLICABLE. DOCUMENT IS REVIEWED AND IT IS CONCLUDED THAT ITS CONTENT IS NOT ACTUAL ANYMORE AND DOES NOT NEED TO BE UPDATED. PURPOSE OF DOCUMENT WAS ORIGINALLY INTENDED AS AN PRE-INPUT FOR CREATING INITIAL REVISION OF THE SERVICE MANUAL. SERVICE MANUAL UPDATE IS CAPTURED UNDER CA2". CA6: QMS-005706 RELEASED WITH DCO#: 40712. ELEAP TRAINING IS PREPARED AND READY FOR SUBMISSION. OTHER ACTIONS TAKEN: REVIEW OF ADDITIONAL RECEIVED COMPLAINTS HAS BEEN COMPLETED. SEVERITY, PROBABILITY AND RISK LEVEL REMAINS UNCHANGED. THERE IS NO NEED FOR UPDATING RISK ASSESSMENT. EFFECTIVITY CHECK TO BE COMPLETED ON CAPA: 004611 ONCE THE CAPA ACTIONS ARE IMPLEMENTED.
UPDATE 08 JULY 2020 (FOLLOW UP 005) (COMPLAINT# (B)(4). INVESTIGATION AND FINDINGS: THE STATUS OF CAPA004611 IS CURRENTLY AT IMPLEMENTING ACTIONS AND IS ON TRACK. CORRECTIVE ACTION PLAN CAPA004611. CA 1: USER GUIDE (7-50-1220-XX) UPDATE - INCLUDING TRANSLATIONS. MAINTENANCE TO INCLUDE ANNUAL BATTERY EXCHANGE. ( DUE OCT. 1, 2020). CA 2: SERVICE MANUAL (7-50-1050-EN) UPDATE. MAINTENANCE TO INCLUDE ANNUAL BATTERY EXCHANGE. (DUE AUG. 1, 2020). CA 3: REFERENCE MANUAL (7-50-0930-EN) UPDATE. MAINTENANCE TO INCLUDE ANNUAL BATTERY EXCHANGE. (DUE AUG. 1, 2020). CA 4: CHANGE BATTERY (8-73-02200 WHERE USED IN 1053 BOMS). (DUE DEC. 1, 2020). CA 5: SERVICE SPEC. (0-80-00311) UPDATE. GENERAL REVIEW, TEMPLATE AND BATTERY EXCHANGE (DUE DEC. 1, 2020). CA 6: CREATE NEW SERVICE NOTE INCLUDING IMPLEMENTATION. ANNUAL BATTERY EXCHANGE (DUE JUL. 1, 2020). ALL CORRECTIVE ACTIONS CAN BE COMPLETED INDEPENDENTLY. OVERALL STATUS: ON TRACK. CA1: ACTION OWNER ASSIGNED. CA2: ACTION OWNER ASSIGNED. CA3: ACTION OWNER ASSIGNED. CA4: WORK INITIATED. NEW BATTERY IDENTIFICATION IS IN PROGRESS. CA5: WORK INITIATED. DOCUMENT REVIEWED AND IT IS CONCLUDED THAT DOCUMENT AND ITS CONTENT IS NOT ACTUAL ANYMORE. PLAN IS TO MAKE IT INACTIVE WITH A "NOT APPLICABLE" RATIONALE. CA6: QMS-005706 RELEASED WITH DCO#40712. ELEAP TRAINING IS PREPARED AND READY FOR SUBMISSION. EFFECTIVITY CHECK TO BE COMPLETED ON CAPA004611 ONCE THE CAPA ACTIONS ARE IMPLEMENTED.
PATIENT INFORMATION: NO PATIENT INJURY REPORTED, DEVICE MALFUNCTION OCCURRED. RELEVANT TESTS / LABORATORY DATA: THIS SECTION IS NOT APPLICABLE AS NO PATIENT INJURY OCCURRED. OTHER RELEVANT HISTORY, INCLUDING PREEXISTING MEDICAL CONDITIONS: THIS SECTION IS NOT APPLICABLE AS NO PATIENT INJURY OCCURRED. SUSPECT PRODUCTS: NOT APPLICABLE THIS SECTION IS NOT APPLICABLE AS THE MEDICAL DEVICE IS NOT IMPLANTABLE. THIS SECTION IS NOT APPLICABLE AS THE MEDICAL DEVICE IS NOT IMPLANTABLE. THIS SECTION IS NOT APPLICABLE AS THE MEDICAL DEVICE IS NOT A SINGLE-USE DEVICE THAT WAS REPROCESSED OR REUSED ON A PATIENT. THIS SECTION IS NOT APPLICABLE TO THIS TYPE OF DEVICE NOT APPLICABLE AS WE ARE NOT A FACILITY OR IMPORTER OF DEVICE. THIS SECTION IS NOT APPLICABLE AS THE MEDICAL DEVICE IS NOT IND. THIS SECTION IS NOT APPLICABLE TO MEDICAL DEVICES. THIS SECTION IS NOT APPLICABLE AS NO REMEDIAL ACTION WAS INITIATED. THIS SECTION IS NOT APPLICABLE AS THERE WAS NO ACTION REPORTED UNDER 21USC 360I(F).
UPDATE 30 SEPT 2020 (FOLLOW UP 008) (B)(4). THE STATUS OF CAPA004611 IS CURRENTLY AT IMPLEMENTING ACTIONS AND IS ON TRACK. CORRECTIVE ACTION PLAN CAPA004611 CA 1: USER GUIDE UPDATE - INCLUDING TRANSLATIONS. MAINTENANCE TO INCLUDE ANNUAL BATTERY EXCHANGE. ( DUE OCT. 1, 2020). CA 2: SERVICE MANUAL UPDATE. MAINTENANCE TO INCLUDE ANNUAL BATTERY EXCHANGE. (DUE AUG. 1, 2020). CA 3: REFERENCE MANUAL UPDATE. MAINTENANCE TO INCLUDE ANNUAL BATTERY EXCHANGE. (DUE AUG. 1, 2020). CA 4: CHANGE BATTERY WHERE USED IN 1053 BOMS. (DUE DEC. 1, 2020). CA 5: SERVICE SPEC UPDATE. GENERAL REVIEW, TEMPLATE AND BATTERY EXCHANGE (DUE DEC. 1, 2020). CA 6: CREATE NEW SERVICE NOTE INCLUDING IMPLEMENTATION. ANNUAL BATTERY EXCHANGE (DUE JUL. 1, 2020). OVERALL STATUS: ON TRACK. CA1: -PROTO VERSION OF IFU SUBMITTED. CA2: -PROTO VERSION OF IFU SUBMITTED. CA3: -PROTO VERSION OF IFU SUBMITTED. CA4: NEW BATTERY IDENTIFIED. SUSTAINING DESIGN CHANGE INITIATED. CA5: COMPLETED WITH THIS RATIONALE: "TASK IS NOT APPLICABLE. DOCUMENT IS REVIEWED AND IT IS CONCLUDED THAT ITS CONTENT IS NOT ACTUAL ANYMORE AND DOES NOT NEED TO BE UPDATED. PURPOSE OF DOCUMENT WAS ORIGINALLY INTENDED AS AN PRE-INPUT FOR CREATING INITIAL REVISION OF THE SERVICE MANUAL. SERVICE MANUAL UPDATE IS CAPTURED UNDER CA2". CA6: QMS-005706 DOCUMENT RELEASED . TRAINING IS PREPARED AND READY FOR SUBMISSION. OTHER ACTIONS TAKEN: REVIEW OF ADDITIONAL RECEIVED COMPLAINTS HAS BEEN COMPLETED. SEVERITY, PROBABILITY AND RISK LEVEL REMAINS UNCHANGED. THERE IS NO NEED FOR UPDATING RISK ASSESSMENT. EFFECTIVITY CHECK TO BE COMPLETED ON CAPA004611 ONCE THE CAPA ACTIONS ARE IMPLEMENTED.
THE CUSTOMER HAS REPORTED THAT THE BATTERY COMPARTMENT OF THE FREE FIT IS DEFECTIVE AND THAT THE BATTERY HAS EXPLODED AND MELTED.
BATTERY COMPARTMENT DEFECTIVE, BATTERY HAS "EXPLODED" THE BATTERY COMPARTMENT MELTED. NO PATIENT INJURY.
BATTERY COMPARTMENT DEFECTIVE, BATTERY HAS "EXPLODED" THE BATTERY COMPARTMENT MELTED. NO PATIENT INJURY.
BATTERY COMPARTMENT DEFECTIVE, BATTERY HAS "EXPLODED" THE BATTERY COMPARTMENT MELTED. NO PATIENT INJURY.
BATTERY COMPARTMENT DEFECTIVE, BATTERY HAS "EXPLODED" THE BATTERY COMPARTMENT MELTED.
BATTERY COMPARTMENT DEFECTIVE, BATTERY HAS "EXPLODED" THE BATTERY COMPARTMENT MELTED. NO PATIENT INJURY.
BATTERY COMPARTMENT DEFECTIVE, BATTERY HAS "EXPLODED" THE BATTERY COMPARTMENT MELTED.
THE CUSTOMER HAS REPORTED THAT THE BATTERY COMPARTMENT OF THE FREE FIT IS DEFECTIVE AND THAT THE BATTERY HAS EXPLODED AND MELTED.
BATTERY COMPARTMENT DEFECTIVE, BATTERY HAS "EXPLODED" THE BATTERY COMPARTMENT MELTED. NO PATIENT INJURY.
A QUESTIONNAIRE WAS SENT TO THE CUSTOMER TO GAIN FURTHER INFORMATION ON THE COMPLAINT. IT WAS ALSO REQUESTED FOR THE DEVICE TO BE RETURNED FOR INVESTIGATION. THE DEVICE HAS BEEN RETURNED BUT INVESTIGATION IS NOT YET COMPLETE. CAPA(B)(4) HAS ALSO BEEN OPENED TO INVESTIGATE FURTHER.
UPDATE 03 SEPT 2020 (FOLLOW UP 007) (COMPLAINT#(B)(4)). THE STATUS OF CAPA(B)(4) IS CURRENTLY AT IMPLEMENTING ACTIONS AND IS ON TRACK. CORRECTIVE ACTION PLAN CAPA(B)(4). CA 1: USER GUIDE UPDATE - INCLUDING TRANSLATIONS. MAINTENANCE TO INCLUDE ANNUAL BATTERY EXCHANGE. ( DUE OCT. 1, 2020). CA 2: SERVICE MANUAL UPDATE. MAINTENANCE TO INCLUDE ANNUAL BATTERY EXCHANGE. (DUE AUG. 1, 2020). CA 3: REFERENCE MANUAL UPDATE. MAINTENANCE TO INCLUDE ANNUAL BATTERY EXCHANGE. (DUE AUG. 1, 2020). CA 4: CHANGE BATTERY WHERE USED IN 1053 BOMS. (DUE DEC. 1, 2020). CA 5: SERVICE SPEC UPDATE. GENERAL REVIEW, TEMPLATE AND BATTERY EXCHANGE (DUE DEC. 1, 2020). CA 6: CREATE NEW SERVICE NOTE INCLUDING IMPLEMENTATION. ANNUAL BATTERY EXCHANGE (DUE JUL. 1, 2020). OVERALL STATUS: ON TRACK. CA1: DRAFT PREPARED AND REVIEWED. CA2: DRAFT PREPARED AND REVIEWED. CA3: DRAFT PREPARED AND REVIEWED. CA4: NEW BATTERY IDENTIFIED. SUSTAINING DESIGN CHANGE INITIATED. CA5: COMPLETED WITH THIS RATIONALE: "TASK IS NOT APPLICABLE. DOCUMENT IS REVIEWED AND IT IS CONCLUDED THAT ITS CONTENT IS NOT ACTUAL ANYMORE AND DOES NOT NEED TO BE UPDATED. PURPOSE OF DOCUMENT WAS ORIGINALLY INTENDED AS AN PRE-INPUT FOR CREATING INITIAL REVISION OF THE SERVICE MANUAL. SERVICE MANUAL UPDATE IS CAPTURED UNDER CA2". CA6: (B)(4) DOCUMENT RELEASED . TRAINING IS PREPARED AND READY FOR SUBMISSION. OTHER ACTIONS TAKEN: REVIEW OF ADDITIONAL RECEIVED COMPLAINTS HAS BEEN COMPLETED. SEVERITY, PROBABILITY AND RISK LEVEL REMAINS UNCHANGED. THERE IS NO NEED FOR UPDATING RISK ASSESSMENT. EFFECTIVITY CHECK TO BE COMPLETED ON CAPA(B)(4) ONCE THE CAPA ACTIONS ARE IMPLEMENTED.
UPDATE 17 APRIL 2020, CAPA(B)(4) HAS BEEN INITIATED TO INVESTIGATE BATTERY MELTING ISSUE. ROOT CAUSE OF FAILURE HAS BEEN ATTRIBUTED TO STRESS PLACED ON THE BATTERY CAUSED BY REPEATEDLY OVERCHARGING DUE TO CHARGING PROCEDURES CONTROLLED BY IMPLEMENTED FIRMWARE IN COMBINATION WITH ACTUAL USE SCENARIO. CORRECTIVE ACTION PLAN IS INWORKS AND WILL INVOLVE. IFU UPDATE. MAINTENANCE TO INCLUDE ANNUAL BATTERY EXCHANGE. SERVICE MANUAL. MAINTENANCE TO INCLUDE ANNUAL BATTERY EXCHANGE. CHANGE BATTERY TYPE.
THE CUSTOMER HAS REPORTED THAT THE BATTERY COMPARTMENT OF THE FREE FIT IS DEFECTIVE AND THAT THE BATTERY HAS EXPLODED AND MELTED.
BATTERY COMPARTMENT DEFECTIVE, BATTERY HAS "EXPLODED" THE BATTERY COMPARTMENT MELTED. NO PATIENT INJURY.
BATTERY COMPARTMENT DEFECTIVE, BATTERY HAS "EXPLODED" THE BATTERY COMPARTMENT MELTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 205632 | 1053 AURICAL FREEFIT | 1053 AURICAL FREEFIT | ETW | NATUS MEDICAL DENMARK | 8-04-11804 | 184640 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Other |