BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    P312 / PURE 500

    MDR report key: 3555158 · Received November 14, 2013

    Report

    Report Number
    3005019184-2013-00004
    Event Type
    Malfunction
    Date Received
    November 14, 2013
    Date of Event
    October 11, 2009
    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

    THIS 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 ON 02/19/2010. 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. AS OF TODAY, (B)(4) MORE BATTERY EXPANSION INCIDENTS HAVE COME TO OUR ATTENTION AND WILL BE REPORTED ON SEPARATE 3500A WITH REFERENCE TO THIS REPORT SHORTLY.

    Description of Event or Problem · 1

    A CUSTOMER WAS WEARING THE SIEMENS PURE 500 HEARING INSTRUMENT ON HIS RIGHT EAR. AS USUAL, THE HEARING INSTRUMENT WAS CHARGED OVERNIGHT. WHILE WEARING THE HEARING INSTRUMENT, THE CUSTOMER HEARD A LOUD SOUND. THE CUSTOMER IMMEDIATELY REMOVED THE HEARING INSTRUMENT FROM BEHIND THE EAR AND REALIZED THAT THE BATTERY COMPARTMENT HAD OPENED ITSELF. THE EXPANDED RECHARGEABLE BATTERY WAS REMOVED FROM THE HEARING INSTRUMENT. THE HEARING INSTRUMENT AND THE DESTROYED RECHARGEABLE BATTERY WERE PLACED, 2 CM APART FROM EACH OTHER, ON A SHEET OF PAPER AND ON A SHELF. SOON AFTER, THE DEFECTIVE RECHARGEABLE BATTERY STARTED TO BURN. THE NEARBY HEARING INSTRUMENT WAS ALSO BURNED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    591200 P312 / PURE 500 RECHARGEABLE BATTERY / HEARING AID ESD SIEMENS HEARING INSTRUMENTS, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1