BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    P312 / PURE 501

    MDR report key: 4368127 · Received December 16, 2014

    Report

    Report Number
    2217809-2014-00001
    Event Type
    Malfunction
    Date Received
    December 16, 2014
    Date of Event
    November 17, 2014
    Report Date
    December 16, 2014
    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

    INVESTIGATION OF THE HEARING AID AND RECHARGEABLE BATTERY INDICATED NO DISCERNIBLE LIQUID VISIBLE. THE RECHARGEABLE BATTERY SEAM HAD EXPANDED, ACTING AS A RELEASE VALVE. THE HEARING AID WAS INVOICED ON (B)(6) 2010 AND THE BATTERY DATE CODE INDICATED THE 28TH DAY OF 2011 (VERSION 2). REVERSE CHARGING IS THE PROBABLE CAUSE OF THE DEFECT. REVERSE CHARGING MAY BE CAUSED BY INSERTING DEVICES IN AN INCORRECT ORIENTATION INTO THE CHARGER 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. SINCE THE INVOICING OF THIS HEARING IN (B)(6) 2010.

    Description of Event or Problem · 1

    THE PT REMOVED THE HEARING AID FROM THE BATTERY CHARGER. THE PT OPENED UP THE BATTERY DOOR AND THE BATTERY MADE A POPPING SOUND AND LEAKED A SUBSTANCE ONTO THE PT'S HAND. THE PT'S HAND RECEIVED A SMALL BURN, BUT DID NOT REQUIRE MEDICAL TREATMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    826681 P312 / PURE 501 RECHARGEABLE BATTERY / HEARING AID ESD SIEMENS HEARING INSTRUMENTS, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1