BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    P312 / PURE 500

    MDR report key: 3555157 · Received November 14, 2013

    Report

    Report Number
    3005019184-2013-00005
    Event Type
    Malfunction
    Date Received
    November 14, 2013
    Date of Event
    March 1, 2010
    Report Date
    November 14, 2013
    Manufacturer
    SIEMENS HEARING INSTRUMENTS, INC.
    Product Code
    ESD
    PMA / PMN Number
    NA
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    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. 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

    ON (B)(6) 2010 A PT IN (B)(6) WAS WEARING HIS PURE 500 HEARING AID WHILE THE RECHARGEABLE BATTERY EXPANDED. HE REMOVED THE DEVICE AND PUT IT ON A TABLE. THE CASE OF THE DEVICE HAD LOOSENED AND IT WASN'T OPERATIONAL, THE BATTERY HAD DISINTEGRATED. THE BATTERY IGNITED SHORTLY AFTER AND BURNED. THE PT DID NOT INDICATE ANY EFFECT ON HIS HEALTH WHEN HE REPORTED THE INCIDENT TO HIS DISPENSER AT THE DAY OF THE EVENT. WHEN HE RETURNED TO PICK UP A REPLACEMENT DEVICE ON (B)(6) 2010; HOWEVER, HE CLAIMED HE WAS HEARING A BUZZ IN HIS EARS AFTER THE BATTERY EXPANDED. HE WAS THEN OFFERED A MEDICAL EXAMINATION AND A HEARING TEST, BOTH CONDUCTED ON (B)(6) 2010. HIS HEARING WAS UNCHANGED IN COMPARISON TO HIS LAST TEST RESULT OF (B)(6) 2008 AND THE MEDICAL EVALUATION SHOWED NO FINDINGS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    591623 P312 / PURE 500 RECHARGEABLE BATTERY / HEARING AID ESD SIEMENS HEARING INSTRUMENTS, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1