BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AUTOPULSE NIMH BATTERY

    MDR report key: 2935297 · Received January 25, 2013

    Report

    Report Number
    3003793491-2012-00385
    Event Type
    Malfunction
    Date Received
    January 25, 2013
    Date of Event
    May 1, 2012
    Report Date
    May 10, 2012
    Manufacturer
    ZOLL CIRCULATION, INC.
    Product Code
    DRM
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    BATTERY WAS NOT RETURNED FOR INVESTIGATION. THE CUSTOMER SCRAPPED THE BATTERY, BUT HAD TESTED IT AND PROVIDED THE DATA. BASED ON THIS DATA: BATTERY WAS TESTED; IT PASSED POWER TESTING. PROBABLE CAUSE FOR THE REPORTED "REPLACE BATTERY" MESSAGES MIGHT HAVE BEEN DUE TO THE USE OF ANY OF THE 6 FAILED BATTERIES.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT PT WAS IN CARDIAC ARREST, DURING USE, DEVICE COMPRESSED ONCE AND DISPLAYED "REPLACE BATTERY". BATTERY WAS REPLACED, SYSTEM AGAIN COMPRESSED ONCE AND DISPLAYED REPLACE BATTERY. MANUAL CPR WAS ADMINISTERED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    36120 AUTOPULSE NIMH BATTERY NIMH BATTERY DRM ZOLL CIRCULATION, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 Death