BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AUTOPULSE NIMH BATTERY

    MDR report key: 2953896 · Received January 11, 2013

    Report

    Report Number
    3003793491-2013-00083
    Event Type
    Malfunction
    Date Received
    January 11, 2013
    Date of Event
    December 13, 2012
    Report Date
    December 13, 2012
    Manufacturer
    ZOLL CIRCULATION, INC.
    Product Code
    DRM
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, 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. NO ADVERSE EVENT REPORTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PLATFORM WAS WORKING FOR ABOUT TEN MINUTES AT WHICH TIME THE MEDIC STOPPED IT TO A QUICK PULSE CHECK, WHEN HE ATTEMPTED TO RE-START THE PLATFORM, CHECK BATTERY MESSAGE WAS INDICATED AND THE PLATFORM WOULD NOT START. ANOTHER BATTERY WAS TRIED WITH THE SAME RESULT. MANUAL CPR WAS ADMINISTERED. CUSTOMER INDICATED THAT THE PLATFORM TESTED FINE DURING THE DAILY CHECK. AFTER RETURNING TO THE STATION, CUSTOMER TESTED THE PLATFORM WITH A DIFFERENT BATTERY, NO ISSUES WERE OBSERVED. THE TWO BATTERIES IN QUESTION (SN (B)(4)) WERE PUT INTO THE CHARGER AND SHOWED NO INDICATION OF HAVING A PROBLEM. NO ADVERSE EVENT REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    17514 AUTOPULSE NIMH BATTERY NIMH BATTERY DRM ZOLL CIRCULATION, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 Other