BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AUTOPULSE NIMH BATTERY

    MDR report key: 2933055 · Received January 18, 2013

    Report

    Report Number
    3003793491-2012-00239
    Event Type
    Malfunction
    Date Received
    January 18, 2013
    Manufacturer
    ZOLL CIRCULATION, INC.
    Product Code
    DRM
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE BATTERY PASSED TESTING. HOWEVER, THE ARCHIVE FILE INDICATED THAT IT WAS NOT PROPERLY MAINTAINED, IT ONLY HAD 2 TEST CYCLES DURING THE PERIOD FROM ON (B)(6) 2011 AND (B)(6) 2012 (6 1/2 MONTHS). ARCHIVE FILE ALSO CONTAINED MAINTENANCE DATA FOR TWO OTHER BATTERIES ((B)(4)), WHICH WERE NOT RETURNED FOR EVALUATION, AND WERE NOT MAINTAINED PROPERLY. THE BATTERY IDENTIFIED WITH SERIAL# (B)(4) WAS NOT TEST CYCLED DURING THE PERIOD FROM ON (B)(6) 2011 TO (B)(6) 2012 (4 MONTHS). BATTERY IDENTIFIED WITH SERIAL# (B)(4) WAS NOT TEST CYCLED DURING THE PERIOD FROM ON (B)(6) 2011 TO (B)(6) 2012 (2 MONTHS). BATTERY MANAGEMENT PROGRAM LITERATURE INDICATES THAT THE BATTERY SHOULD BE TEST CYCLED ON A MONTHLY BASIS. BASED ON THE BATTERY MAINTENANCE DATA, THE MOST LIKELY CAUSE FOR THE UNIT STOPPING COMPRESSION IS THE USE OF BATTERIES THAT ARE WEAK DUE TO IMPROPER BATTERY MANAGEMENT. NO INFORMATION ABOUT PATIENT CONDITION WAS PROVIDED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT UNIT STOPPED DURING COMPRESSION ON PATIENT. CUSTOMER INDICATED THAT ALL THEIR BATTERIES HAVE RECENTLY BEEN REPLACED AND THE BATTERY CHARGER WAS RECENTLY REPAIRED. CUSTOMER ALSO STATED THAT THEY HAVE DISCONTINUED USING THE SYSTEMS AND WOULD LIKE TO KNOW WHY THE SYSTEMS ARE FAILING EVERY TIME THEY ARE USED. THIS REPORT PERTAINS TO THE BATTERY IDENTIFIED WITH SERIAL# (B)(4), WHICH WAS RETURNED WITH THE AUTOPULSE RESUSCITATION SYSTEM DISCUSSED IN REPORT# 3003793491-2012-00237.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    28546 AUTOPULSE NIMH BATTERY NIMH BATTERY DRM ZOLL CIRCULATION, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1