BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    P312/ PURE 300

    MDR report key: 3555163 · Received November 14, 2013

    Report

    Report Number
    3005019184-2013-00006
    Event Type
    Malfunction
    Date Received
    November 14, 2013
    Date of Event
    June 18, 2010
    Report Date
    November 14, 2013
    Manufacturer
    SIEMENS HEARING INSTRUMENTS INC
    Product Code
    ESD
    PMA / PMN Number
    NA
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE REPORT WAS FILED LATE BECAUSE THE INCIDENT WAS INCORRECTLY CLASSIFIED AS NOT MDR REPORTABLE. A RETROSPECTIVE REVIEW OF COMPLAINTS; HOWEVER, IDENTIFIED THIS INCIDENT AS MDR REPORTABLE. REVERSE CHARGING IS THE PROBABLE CAUSE OF THE DEFECT. REVERSE CHARGING MAY BE CAUSED BY INSERTING DEVICES IN AN INCORRECT ORIENTATION INTO THE CHARGING STATION WITH SOME FORCE. THIS SITUATION COULD EASILY BE DETECTED, SINCE THE TOP OF THE CHARGER CANNOT BE SHUT AND PARTS OF THE HEARING AIDS WOULD REMAIN EXPOSED. REVERSE CHARGING MAY ALSO BE CAUSED BY INSERTING THE BATTERIES IN THE HEARING AID WITH WRONG ORIENTATION BY APPLYING SOME FORCE. STANDARD BATTERIES ARE JUST SLIGHTLY ASYMMETRIC, RESULTING IN A NOT TOO OBVIOUS SLIGHT SPREADING OF THE HEARING AID CASE. A LETTER WITH THE INVESTIGATION RESULTS WAS SENT TO THE ACOUSTICIAN. THE CHARGER USER GUIDE WAS UPDATED TO CONTAIN MORE SPECIFIC WARNINGS REGARDING THE HANDLING OF BATTERIES AND INSTRUMENTS TO REDUCE THE LIKELIHOOD OF ACCIDENTAL REVERSE CHARGING.

    Description of Event or Problem · 1

    THE HEARING AID USER WAS WEARING HIS PURE 300 HEARING AIDS WHILE RIDING IN THE PASSENGER SEAT OF A CAR. HIS WIFE WAS DRIVING. THE RECHARGEABLE BATTERY OF THE RIGHT HEARING AID EXPANDED WITH A LOUD BANG AND FELL OUT OF THE HEARING AID IN PIECES. SOON SMOKE APPEARED, ORIGINATING FROM THE USER'S TROUSERS AND THE PASSENGER SEAT COVER. PARTS OF THE RECHARGEABLE BATTERY HAD DROPPED ON THE CAR SEAT AND TROUSERS AND BURNED HOLES INTO BOTH FABRICS. RECHARGEABLE BATTERIES WERE CHARGED ONCE A DAY IN THE EVENING AND WERE USED IN THE MORNING. DAILY OPERATION WAS ABOUT 10-12 HOURS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    591422 P312/ PURE 300 RECHARGEABLE BATTERY/ HEARING AID ESD SIEMENS HEARING INSTRUMENTS INC

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR