BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    1053 FREEFIT MODULE

    MDR report key: 12201660 · Received July 21, 2021

    Report

    Report Number
    9612197-2021-00011
    Event Type
    Malfunction
    Date Received
    July 21, 2021
    Date of Event
    July 13, 2021
    Report Date
    December 9, 2021
    Manufacturer
    NATUS MEDICAL DENMARK APS
    Product Code
    ETW
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    INITIAL REPORT REF COMPLAINT# (B)(4). CORRECTION TO SECTION B1., H1., SECTION D4., UNIQUE IDENTIFIER (UDI) PROVIDED AS (B)(4). AWAITING RETURN OF AFFECTED PRODUCT.

    Additional Manufacturer Narrative · 0

    FOLLOW UP REPORT 002 REF COMPLAINT# (B)(4). THE AFFECTED DEVICE WAS RETURNED. REPAIR NOTES AS FOLLOWS: FREEFIT REPLACED WITH NEW ATO (B)(6) DUE TO BATTERY COMPARTMENT DAMAGED. DAMAGED BATTERY REPLACED WITH NEW(NI-MH). DAMAGED BATTERY LID CHANGED WITH NEW. PROBES CALIBRATED. FUNCTION AND FINAL TEST PERFORMED. REPAIRED DEVICE SHIPPED (B)(6) 2021 (B)(6). CAPA004611 ADDRESSED THE ISSUE DESCRIBED IN THIS CASE - REFERENCE TO STRESS PLACED ON THE BATTERY CAUSED BY REPEATEDLY OVERCHARGING DUE TO CHARGING PROCEDURES CONTROLLED BY IMPLEMENTED FIRMWARE IN COMBINATION WITH ACTUAL USE SCENARIO. THE FAILURE DESCRIBED IN THIS CASE IS PRIOR TO THE IMPLEMENTATION OF THE CORRECTIVE ACTIONS IN CAPA004611. CORRECTIVE ACTION PLAN THAT WAS IMPLEMENTED: 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. EFFECTIVITY CHECK PLAN CARRIED OUT ON CAPA004611: COMPLAINT TRENDING ON THE FAILURE MODE (MELTING PLASTIC IN BATTERY COMPARTMENT) TO BE CARRIED OUT TO MEASURE THE EFFECTIVENESS OF THE CORRECTIVE ACTION(S) IN REDUCING THE COMPLAINTS RECEIVED. (REFERENCE - NEW BATTERY IS PART NO. 031814 - PANASONIC: BK200AAB). ACCEPTANCE CRITERIA: PASS: < (B)(4) COMPLAINT INVOLVING THE NEW BATTERY. FAIL: > (B)(4) COMPLAINT INVOLVING THE NEW BATTERY. SUMMARY OF EFFECTIVITY ANALYSIS: COMPLAINT ANALYSIS WAS CARRIED OUT WHICH CONCLUDED THAT THERE WERE NO RELATED FAILURE MODE COMPLAINTS RECEIVED RELATING TO THE NEW BATTERY MODEL. THE DEVICE HISTORY RECORD WAS REVIEWED AND PRODUCT PASSED ALL TESTS ACCORDING TO THE CONTRACTED MANUFACTURER. A SEARCH FOR SERVICE DATA THAT MAY BE RELEVANT TO THIS ISSUE HAS BEEN CONDUCTED. NO FURTHER INFORMATION RELATED TO THIS DEVICE FOUND. THE CURRENT RISK FILE (B)(4) REV 03 HAZARD ID 6.6 IDENTIFIES THIS ISSUE: HARM - MINOR INJURY TO THE PATIENT OR USER OR DISCOMFORT. CAUSE - EXCESSIVE TEMPERATURES WHEN IN CONTACT WITH THE DEVICE DUE TO BATTERY FAILURE (I.E. BATTERY SHORT CIRCUIT DURING CHARGING CAUSES RAPID RELEASE OF ENERGY THAT INCREASES THE ENCLOSURE / BATTERY TEMPERATURES.). SEVERITY - MARGINAL (3). RISK LEVEL - MINOR (3). A RISK REVIEW IS NOT REQUIRED AS THIS COMPLAINT DOES NOT DESCRIBE A NEW FAILURE MODE OR NEW HARM AND THE EXISTING HAZARD SEVERITY AND/OR PROBABILITY OF OCCURRENCE HAS NOT CHANGED. REVIEW OF ADDITIONAL RECEIVED COMPLAINTS HAS BEEN COMPLETED. SEVERITY, PROBABILITY AND RISK LEVEL REMAINS UNCHANGED. THERE IS NO NEED FOR UPDATING RISK ASSESSMENT. INVESTIGATION RESULT CODE: TAASTRUP/BATTERY. CLOSURE RATIONALE: COMPLAINT VERIFIED, CAPA INITIATED OR ALREADY OPEN.

    Description of Event or Problem · 0

    CUSTOMER REPORTS MELTING DAMAGE TO THE FREEFIT DEVICE.

    Description of Event or Problem · 0

    CUSTOMER REPORTS MELTING DAMAGE TO THE FREEFIT DEVICE.

    Additional Manufacturer Narrative · 1

    INITIAL REPORT REF COMPLAINT# (B)(4). CUSTOMER REPORTS MELTING DAMAGE TO THE FREEFIT DEVICE. PRODUCT EXAMINATION, FUNCTIONAL TESTING PERFORMED ON-SITE, AND CAUSE WAS DETERMINED. THE PRODUCT IS REQUESTED FOR RETURN. CAPA (B)(4) ADDRESSES THE ISSUE DESCRIBED IN THIS CASE. THE FAILURE DESCRIBED IN THIS CASE IS PRIOR TO THE IMPLEMENTATION OF ACTIONS IN CAPA (B)(4). THE CURRENT RISK FILE (B)(4) IDENTIFIES THIS ISSUE: HARM - MINOR INJURY TO THE PATIENT OR USER OR DISCOMFORT. CAUSE- EXCESSIVE TEMPERATURES WHEN IN CONTACT WITH THE DEVICE DUE TO BATTERY FAILURE (I.E. BATTERY SHORT CIRCUIT DURING CHARGING CAUSES RAPID RELEASE OF ENERGY THAT INCREASES THE ENCLOSURE / BATTERY TEMPERATURES.). SEVERITY- MARGINAL (3). RISK LEVEL- MINOR (3). A RISK REVIEW IS NOT REQUIRED AS THIS COMPLAINT DOES NOT DESCRIBE A NEW FAILURE MODE OR NEW HARM AND THE EXISTING HAZARD SEVERITY AND/OR PROBABILITY OF OCCURRENCE HAS NOT CHANGED.

    Description of Event or Problem · 1

    CUSTOMER REPORTS MELTING DAMAGE TO THE FREEFIT DEVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1097861 1053 FREEFIT MODULE 1053 FREEFIT MODULE ETW NATUS MEDICAL DENMARK APS 8-62-49100

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown