BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    STARKEY HEARING TECHNOLOGIES CHARGER

    MDR report key: 10550398 · Received September 17, 2020

    Report

    Report Number
    2125608-2020-00001
    Event Type
    Malfunction
    Date Received
    September 17, 2020
    Date of Event
    July 8, 2020
    Report Date
    September 4, 2020
    Manufacturer
    STARKEY LABORATORIES, INC.
    Product Code
    OSM
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    THE USER REPORTED THAT, ABOUT 10 MINUTES AFTER CHARGING STARTED, A NOISE AND SOME SMOKE PROMPTED HIM TO CHECK THE CHARGER. THE USER DISCOVERED THAT THE CHARGER OVERHEATED CAUSING PART OF THE PLASTICS TO MELT. THE MELTED BOTTOM SIDE OF THE CHARGER LEFT NOTICEABLE MARK ON THE DESK. THIS CHARGER HAS AN INTERNAL BATTERY CHARGED BY 5-VOLT POWER SUPPLY. A DEFINITIVE ROOT CAUSE FOR THIS EVENT CANNOT BE DETERMINED SINCE THE BATTERY CELL AND HEARING AID CHARGER ARE COMPLETELY DESTROYED/MELTED. THE ANALYSIS OF INCIDENT BATTERY CELL SUGGESTS THAT AN ELECTRICAL SHORT CIRCUIT IN BATTERY ITSELF LIKELY INITIATED THE THERMAL RUNAWAY EVENT RESULTING IN MELTING OF HEARING AID CHARGER. HOWEVER, THERE IS NO EVIDENCE OF ANY SYSTEMIC ISSUES WITH BATTERIES USED IN THESE HEARING AID CHARGERS AND NO REASON TO BELIEVE THAT THE HEARING AID CHARGERS IN USE WITH CUSTOMERS ARE AT ANY RISK OF RESULTING IN A SIMILAR EVENT AS OBSERVED IN THE REPORTED EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1016268 STARKEY HEARING TECHNOLOGIES CHARGER HEARING AID CHARGER OSM STARKEY LABORATORIES, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR