BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AUTOPULSE NIMH BATTERY

    MDR report key: 2932993 · Received December 31, 2012

    Report

    Report Number
    3003793491-2012-00651
    Event Type
    Malfunction
    Date Received
    December 31, 2012
    Date of Event
    October 30, 2012
    Report Date
    October 30, 2012
    Manufacturer
    ZOLL CIRCULATION, INC.
    Product Code
    DRM
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ZOLL HAS NOT RECEIVED THE PRODUCT FOR EVALUATION AND THIS COMPLAINT IS STILL UNDER INVESTIGATION.

    Description of Event or Problem · 1

    DURING PATIENT USE, THE BATTERY ONLY LASTED ABOUT 1 MINUTE AND ONLY PERFORMED ABOUT 60 COMPRESSIONS. PATIENT WAS (B)(6) MALE AND WEIGH ABOUT (B)(6). NO ADVERSE AFFECTS TO THE PATIENT. CUSTOMER HAD TO PERFORM MANUAL CHEST COMPRESSIONS. BATTERY MANAGEMENT IS IN PLACE. THE BATTERY IS FAULTY. THE BATTERY SERIAL NUMBER IS (B)(4), MANUFACTURED IN AUGUST OF 2011 AND HAS 21 CYCLES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 AUTOPULSE NIMH BATTERY NIMH BATTERY DRM ZOLL CIRCULATION, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR Other