BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SIEMENS CHARGER TYPE 013-312-04

    MDR report key: 3766061 · Received December 19, 2013

    Report

    Report Number
    3005019184-2013-00020
    Event Type
    Malfunction
    Date Received
    December 19, 2013
    Date of Event
    February 4, 2010
    Report Date
    December 18, 2013
    Manufacturer
    SIEMENS HEARING INSTRUMENTS, INC.
    Product Code
    ESD
    Adverse Event
    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. INVESTIGATION AND CONCLUSION: INVESTIGATION DETERMINED THE POWER ADAPTER LID WITH PINS WAS SEPARATED FROM POWER ADAPTER. AUSTRALIAN POWER SUPPLY ADAPTER FAILED THE SPECIFICATION. CORRECTIVE ACTIONS: (1.) IMMEDIATE ACTION AT (B)(6): LOCAL 100% CHECK FOR ALL POWER SUPPLIES IN (B)(6) BEFORE DELIVERY BY DEFINED TES. (2.) IMMEDIATE ACTION AT SUPPLIER: STOCK AUDIT AND DEFINED 100% CHECK OF ALL ADAPTER BEFORE DELIVERY. (3.) CORRECTIVE ACTION AT MANUFACTURER GLOBTEK: DEFINED PULL TEST ON 1% OF ALL PRODUCED ADAPTERS CONFIRMED BY CERTIFICATE. THE (B)(6) POWER SUPPLY ADAPTER WAS NOT SOLD IN THE U.S.

    Description of Event or Problem · 1

    (B)(6) INCIDENT WHERE THE PATIENT WAS SHOCKED WHILE REMOVING THE HEARING AID BATTERY CHARGER POWER ADAPTER PLUG FORM THE WALL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    666871 SIEMENS CHARGER TYPE 013-312-04 HEARING AID CHARGER ESD SIEMENS HEARING INSTRUMENTS, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1