BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PREMIUM CHARGER

    MDR report key: 12517651 · Received September 23, 2021

    Report

    Report Number
    3005650109-2021-00007
    Event Type
    Malfunction
    Date Received
    September 23, 2021
    Date of Event
    April 23, 2021
    Report Date
    September 23, 2021
    Manufacturer
    GN HEARING A/S
    Product Code
    OSM
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    GN HEARING A/S HAS BECOME AWARE THAT THIS MDR REPORT FAILED SUBMISSION TO FDA WITHOUT OUR NOTICE. THE FDA HELP DESK HAS ADVISED TO RE-SUBMIT THE REPORTS. THIS IS A RE-SUBMISSION OF EXISTING MDR INITIAL SUBMITTED ON (B)(6) 2021. MANUFACTURERS REF# (B)(4). INVESTIGATIONS PERFORMED: THE INVESTIGATION WAS PERFORMED BY A THIRD-PARTY BATTERY EXPERT THAT INCLUDED A FULL ANALYSIS OF THE CASE WITH THE FOLLOWING EVALUATIONS AND TESTING: PHOTO DOCUMENTATION, OPTICAL MICROSCOPY, X-RAY IMAGING, SCANNING ELECTRON MICROSCOPY (SEM)/ENERGY DISPERSIVE X-RAY SPECTROSCOPY (EDS), X-RAY COMPUTED TOMOGRAPHY (CT) IMAGING, FOURIER TRANSFORM INFRARED SPECTROSCOPY (FTIR), ELECTRICAL TESTING, CELL TEARDOWNS OF INCIDENT CELL 2341 AND 2 FIELD RETURN CELLS, FORCED THERMAL RUNAWAY TESTING OF 2 FIELD RETURN DEVICES. X-RAY INSPECTION OF 40 FIELD RETURNED UNITS OF SIMILAR AGE TO THE 2 INCIDENT UNITS TO EVALUATE FOR MISALIGNMENT AND LITHIUM PLATING. DISCUSSIONS AND SITE VISIT WITH BATTERY SUPPLIER AND BATTERY CELL MANUFACTURER. SUMMARY OF ANALYSIS: TWO INCIDENTS HAVE BEEN REPORTED. BOTH INCIDENT CHARGERS ((B)(4), DVPS REF: (B)(4)) WERE PROVIDED TO THE THIRD-PARTY BATTERY EXPERT. THE EXPERT DETERMINED THAT THE TWO INCIDENTS WERE CAUSED BY INTERNAL CELL FAILURES THAT RESULTED IN THERMAL RUNAWAY. THE ROOT CAUSE FOR THE CELL FAILURES WAS NOT DETERMINED. BOTH INCIDENT UNITS HAD CELLS FROM THE SAME DATE CODE ((B)(4)). THE BATTERY IS A STANDARD LITHIUM-ION BATTERY, AND THE BATTERY DESIGN AND CELL DESIGNS WERE DETERMINED TO NOT BE THE CAUSE OF THE INCIDENT. THE FOLLOWING ISSUES WERE AMONG THOSE THAT WERE ELIMINATED AS POTENTIAL ROOT CAUSES OF THE CELL FAILURES: MECHANICAL AND ELECTRICAL STRESS WERE ELIMINATED AS ROOT CAUSES. THERMAL STRESS FROM THE CHARGER WAS ELIMINATED AS A ROOT CAUSE. MISALIGNMENT CAUSING LITHIUM PLATING WITHIN THE BATTERY CELL WAS ELIMINATED AS A ROOT CAUSE. NO EVIDENCE OF LITHIUM PLATING WAS OBSERVED IN FIELD EXPERIENCED CELLS THAT WERE OF SIMILAR AGE TO THE INCIDENT UNITS. CHARGING VOLTAGES WERE ELIMINATED AS A ROOT CAUSE. THE CHARGING VOLTAGES REMAINED BELOW THE BATTERY'S SPECIFIED MAXIMUM CHARGE VOLTAGE. ANALYSIS CONCLUSIONS: A REVIEW OF 40 BATTERIES FROM AROUND THE INCIDENT MANUFACTURING TIME FRAME DID NOT IDENTIFY A SYSTEMIC PROBLEM WITH A CONFIRMED RISK OF ELEVATED FAILURE RATE. BOTH INCIDENT CELLS WERE FROM THE SAME LOT - HAD THE SAME DATE CODE. THE STATISTICAL LIKELIHOOD THAT TWO FAILURES WOULD RANDOMLY OCCUR IN THE SAME LOT IS EXTREMELY LOW. GIVEN THE ABSENCE OF ANY FINDING OF A SYSTEMATIC PROBLEM, AND THE FACT THAT BOTH INCIDENT UNITS HAD CELLS FROM THE SAME LOT, THE ROOT CAUSE IS MOST LIKELY A MANUFACTURING ISSUE WITH THE CELLS FROM THE BATTERIES IN THE INCIDENT UNITS. THE ABSENCE OF ANY ADDITIONAL INCIDENTS OR BENIGN FAILURES FROM THAT DATE CODE INDICATE THAT ANY POTENTIAL MANUFACTURING DEFECT WAS NOT SYSTEMIC WITHIN THAT DATE CODE. THE CELL DESIGN, THE POPULATION IN THE MARKET, THE PRESENCE OF ONLY TWO INCIDENTS, AND THE ANALYZED FIELD RETURNS ALL FAIL TO SUPPORT A FINDING THAT THE FAILURE IS NOT LIFETIME DEPENDENT. THUS, THERE IS NO INDICATION THAT THE LIKELIHOOD FOR THIS INCIDENT WILL INCREASE. CONCLUSION: THE INVESTIGATION CONCLUDED THAT THIS WAS A RANDOMLY OCCURRING ISSUE. IT ALSO FOUND THAT THE HYPOTHESIS THAT THERE IS A SYSTEMIC BATTERY PROBLEM IN EITHER THE ENTIRE PRODUCTION OR CELLS FROM THE (B)(4) DATE CODE WAS NOT SUPPORTED BY THE TESTING AND ANALYSIS. BASED ON THESE FINDINGS, IT IS CONCLUDED THAT THE BENEFIT OF THE END USER OF BEING ABLE TO USE THEIR HEARING AID AND CHARGE IT OUTWEIGHS THE RISK. GN HEARING WILL CONTINUE TO MONITOR FOR SIMILAR EVENTS.

    Description of Event or Problem · 1

    DESCRIPTION OF THE EVENT ACCORDING TO THE REPORTER: CUSTOMER REPORTED A PREMIUM CHARGER SUBJECT TO A THERMAL RUNAWAY AT HOME OF AN END USER. THE END USER INSERTED 2 HEARING INSTRUMENTS (HI) INSIDE THE CHARGER AND CONNECTED IT TO THE SOCKET BEFORE GOING TO BED. DURING THE NIGHT HE WOKE UP BY A LOUD SOUND AND HE FOUND THE CHARGER SUBJECT TO THERMAL RUNAWAY. WATER WAS POURED ON THE CHARGER. THE CHARGER WAS COMPLETELY MELTED AS WELL AS THE HEARING AIDS THAT WERE INSERTED. FURNITURE AND FLOOR OF THE END USER WAS DAMAGED. NO HARM TO THE PATIENT WAS IDENTIFIED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1417783 PREMIUM CHARGER HEARING AID, AIR CONDUCTION WITH WIRELESS TECHNOLOGY OSM GN HEARING A/S CHARGER,LXR,GENERIC

    Patients

    Seq Age Sex Outcome Treatment
    1