BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AUTOPULSE MULTI-CHEMISTRY BATTERY CHARGER

    MDR report key: 2954291 · Received January 9, 2013

    Report

    Report Number
    3003793491-2012-00675
    Event Type
    Malfunction
    Date Received
    January 9, 2013
    Date of Event
    November 17, 2012
    Report Date
    November 21, 2012
    Manufacturer
    ZOLL CIRCULATION INC
    Product Code
    DRM
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    ZOLL MEDICAL CORP HAS NOT YET RECEIVED THE DEVICE. A SUPPLEMENTAL REPORT WILL BE SUBMITTED WHEN THE DEVICE IS RECEIVED AND EVALUATED.

    Description of Event or Problem · 1

    DURING EVENT, FIRST BATTERY LASTED FOR 35-40 MINUTES BEFORE IT NEEDED TO BE REPLACED. WHEN SECOND BATTERY WAS INSERTED INTO THE AUTOPULSE, IT DID NOT POWER UP THE PLATFORM, AT WHICH TIME MANUAL CPR WAS PERFORMED. BOTH BATTERIES WERE LI-ION BATTERIES. SERIAL NUMBER OF THE SECOND BATTERY: (B)(4). WHEN ARRIVED BACK AT STATION, BOTH BATTERIES WERE PUT INTO CHARGER, FIRST BATTERY CHARGED FINE, SECOND BATTERY GAVE THE RED INDICATION LIGHT WITH THE "X" SEEN ON THE CHARGER. CUSTOMER NOW FEELS THE LEFT BAY OF THE CHARGER MAY HAVE POTENTIALLY CAUSED THE PROBLEM AS WELL. THIS REPORT PERTAINS TO THE MULTI-CHEMISTRY CHARGER. THE LI-ION BATTERY IS DISCUSSED IN MFR REPORT # 3003793491-2012-00674.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    11140 AUTOPULSE MULTI-CHEMISTRY BATTERY CHARGER MULTI-CHEMISTRY BATTERY CHARGER DRM ZOLL CIRCULATION INC

    Patients

    Seq Age Sex Outcome Treatment
    1 Other