BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    1053, AURICAL FREEFIT

    MDR report key: 10910935 · Received November 26, 2020

    Report

    Report Number
    9612197-2020-00013
    Event Type
    Malfunction
    Date Received
    November 26, 2020
    Date of Event
    November 17, 2020
    Report Date
    November 25, 2020
    Manufacturer
    NATUS MEDICAL DENMARK
    Product Code
    EWO
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    06 JAN 2021 (REF COMPLAINT#: (B)(4)) FOLLOW UP 001. 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 (B)(4) 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.

    Description of Event or Problem · 0

    BATTERY ISSUE. BATTERY COMPARTMENT MELTED. NO PATIENT INJURY.

    Additional Manufacturer Narrative · 1

    INITIAL REPORT (COMPLAINT# (B)(4)). CAPA#: (B)(4) HAS ALREADY BEEN GENERATED TO INVESTIGATE THIS ONGOING 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. CORRECTIVE ACTION PLAN: CAPA#: (B)(4). 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. OVER ALL STATUS OF CAPA IS ON TRACK: CA1: -PROTO VERSION OF IFU RELEASED WITH ECO# (B)(4). TRANSLATIONS COMPLETED. FINAL ECO# (B)(4) IS SUBMITTED. CA2: -PROTO VERSION OF IFU RELEASED WITH ECO# (B)(4). FINAL ECO#35568 IS SUBMITTED. CA3: -PROTO VERSION OF IFU RELEASED WITH ECO# (B)(4). FINAL ECO#35568 IS SUBMITTED. CA4: NEW BATTERY IDENTIFIED. ECR# (B)(4) IS RELEASED. DCP DOC#: (B)(4) RELEASED. TECH. DESIGN REVIEW DOC#: (B)(4) RELEASED. VERIFICATION PLAN AND PROTOCOL ARE RELEASED. VERIFICATION REPORT IS RELEASED WITH DOC#: (B)(4). BATTERY IS RELEASED WITH ECO#: (B)(4). RII FOR BATTERY IS SUBMITTED WITH DOC#: (B)(4). BOM CHANGES ARE PREPARED WITH ECO#: (B)(4) (AWAITING BATTERY DELIVERY CONFIRMATION). DMR UPDATES ARE PREPARED WITH DOC#: (B)(4) (AWAITING BATTERY DELIVERY CONFIRMATION). 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." 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 (B)(4) ONCE THE CAPA ACTIONS ARE IMPLEMENTED.

    Description of Event or Problem · 1

    BATTERY ISSUE; BATTERY COMPARTMENT MELTED. NO PATIENT INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1377754 1053, AURICAL FREEFIT 1053, AURICAL FREEFIT EWO NATUS MEDICAL DENMARK 8-04-11804

    Patients

    Seq Age Sex Outcome Treatment
    1