BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AUTOPULSE NIMH BATTERY

    MDR report key: 2981299 · Received January 25, 2013

    Report

    Report Number
    3003793491-2012-00319
    Event Type
    Malfunction
    Date Received
    January 25, 2013
    Date of Event
    June 8, 2012
    Report Date
    June 8, 2012
    Manufacturer
    ZOLL CIRCULATION, INC.
    Product Code
    DRM
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    BATTERY IDENTIFIED WITH S/N (B)(4) FAILED TESTING. PROBABLE CAUSE FOR THE FAILURE COULD BE LOW POWER (OUTPUT WAS 1235W INSTEAD OF 1300W). HOWEVER, THE BATTERY STILL OPERATED THE BOARD.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE ZOLL AUTOPULSE WAS USED FOR A CARDIAC ARREST. DURING UTILIZING THIS EQUIPMENT THE MACHINE STOPPED CHEST COMPRESSIONS AND DISPLAYED A CHANGE BATTERY SIGN. THIS HAPPENED TWICE DURING THE CODE WITH BOTH BATTERIES. CUSTOMER ATTEMPTED TO TURN THE UNIT OFF AND PULL BATTERY OUT AND PLACE IT BACK IN THE JUST IN CASE THIS MIGHT FIX THE PROBLEM AS THE BATTERIES WERE CHANGED OUT DURING SHIFT CHANGE IN THE MORNING. END RESULT WAS MANUAL CHEST COMPRESSIONS HAD TO BE UTILIZED TO COMPLETE THE 911 CALL. BATTERIES: 50895, 01/2011. 61955, 03/2012. THIS REPORT PERTAINS TO THE BATTERY IDENTIFIED WITH S/N (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    36355 AUTOPULSE NIMH BATTERY NIMH BATTERY DRM ZOLL CIRCULATION, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 Other