BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    1081, FREEFIT

    MDR report key: 13949909 · Received March 30, 2022

    Report

    Report Number
    9612197-2022-00006
    Event Type
    Malfunction
    Date Received
    March 30, 2022
    Date of Event
    March 28, 2022
    Report Date
    June 8, 2022
    Manufacturer
    NATUS MEDICAL DENMARK APS
    Product Code
    ETW
    UDI-DI
    05713315009051
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SW
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    INITIAL REPORT REF COMPLAINT (B)(4). INSTALLED DATE OF AFFECTED PART: (B)(6) 2014. TECHNICAL SERVICE HAVE REACHED OUT FOR FURTHER INFORMATION. A QUESTIONNAIRE WAS SENT TO THE CUSTOMER 29 MARCH 2022.

    Additional Manufacturer Narrative · 0

    FOLLOW UP REPORT 001 REF COMPLAINT #: (B)(4). THE QUESTIONNAIRE WAS RECEIVED FROM THE CUSTOMER. THE PROCEDURE THAT WAS CARRIED OUT AT THE TIME OF THE EVENT WAS REM ON PATIENTS / MEASUREMENT PREPARATIONS / CHARGING SITUATIONS. THE UNIT SHUTS OFF INTERMITTENTLY (BOTH DURING MEASUREMENT/PREPARATIONS AND ON CHARGER). SOMETIMES WORKS AFTER RESTART. BATTERY SEEMS TO HEAT UP ON CHARGER WHEN THE UNIT SHUTS OFF AND SEEMS UNABLE TO CHARGE. NO INJURIES REPORTED. ALL COMPONENTS OF THE DEVICE WERE RETURNED FOR EVALUATION. THE FOLLOWING WAS CARRIED OUT BY THE SERVICE REPAIR TECHNICIAN: REPAIR NOTES: - DEVICE PASSED ALL TESTS, - PROBES FAILED CALIBRATION AND REPLACED. - PN:8-69-39205 SN: (B)(6). - PN:8-69-39205 SN: (B)(6). - UNIT FULLY TESTS. - BATTERY SENT BY CUSTOMER WAS FAULTY. REPAIRED DEVICE SHIPPED ON 17 MAY 2022. INVESTIGATION RESULT CODE: TAASTRUP/BATTERY. COMPLAINT VERIFIED, BEING TRACKED AS A TREND. DEVICE HISTORY REVIEW IS NOT APPLICABLE BECAUSE, PRIOR TO THE REPORTED ISSUE THE DEVICE WAS IN SERVICE FOR 2 OR MORE YEARS AND A MANUFACTURING DEFECT IS VERY UNLIKELY. A SEARCH FOR SERVICE DATA THAT MAY BE RELEVANT TO THIS ISSUE HAS BEEN CONDUCTED. NO FURTHER INFORMATION RELATED TO THIS ISSUE FOUND. COMPLAINTS ARE REVIEWED ROUTINELY PER QUALITY SYSTEM REQUIREMENTS (QMS-004442 CORPORATE TRENDING AND ANALYSIS PROCEDURE) COMPLAINT TRENDS ARE ASSESSED AS PART OF THESE REVIEWS. A REVIEW OF COMPLAINT TRENDING IS COMPLETED QUARTERLY. LAST REVIEW DOC- 059320. NO TREND FOR THIS FAILURE IDENTIFIED. THE CURRENT RISK FILE DOC-049943 REV 04 - 1053 AURICAL FREEFIT - RISK ANALYSIS 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). 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. THIS ISSUE WAS PREVIOUSLY IDENTIFIED AND CAPA004611 WAS CREATED - 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 IN 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. 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: < 1 COMPLAINT INVOLVING THE NEW BATTERY. FAIL: > 0 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.

    Description of Event or Problem · 0

    UNIT SHUTS OFF INTERMITTENTLY. THE CUSTOMER REPORTS, SOMETIMES IT HELPS TO REMOVE BATTERY, BUT NOT ALWAYS. SOMETIMES IT SHOWS NO CHARGING STATUS (LED DARK) AND THE BATTERY GETS WARM. NO INJURIES REPORTED.

    Description of Event or Problem · 0

    UNIT SHUTS OFF INTERMITTENTLY. THE CUSTOMER REPORTS - SOMETIMES IT HELPS TO REMOVE BATTERY, BUT NOT ALWAYS. SOMETIMES IT SHOWS NO CHARGING STATUS (LED DARK) AND THE BATTERY GETS WARM. NO INJURIES REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2731492 1081, FREEFIT 1081, FREEFIT ETW NATUS MEDICAL DENMARK APS 8-62-45300 05713315009051

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown