BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AUTOPULSE RESUSCITATION SYSTEM MODEL 100

    MDR report key: 2881783 · Received November 7, 2012

    Report

    Report Number
    3003793491-2012-00273
    Event Type
    Malfunction
    Date Received
    November 7, 2012
    Date of Event
    September 24, 2012
    Report Date
    October 9, 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

    THE COMPLAINT OF BOARD STOPPED COMPRESSION WITH 3 BATTERIES WAS NOT VERIFIED. BOARD RAN FOR OVER 25 MINUTES WITH TEST BATTERIES AND THE TEST MANIKIN AND ALSO WITH THE LARGE RESUSCITATION TEST FIXTURE (EQUAL TO A 250 POUND PT FOR 5 MINUTES WITHOUT ANY PROBLEMS. INFO CONCERNING THE CONDITION OF THE PT WAS NOT PROVIDED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING USE ON A PT WITH FULL ARREST, THE BOARD STOPPED WORKING WITHOUT ANY WARNING. A SECOND AND THIRD BATTERY WAS USED WITH THE SAME RESULT. CUSTOMER INDICATED THAT DURING CHARGING, THE BATTERY CHARGER'S GREEN LIGHT HAD COME ON AND THAT THE BATTERIES WERE MAINTAINED ACCORDING TO ZOLL GUIDELINES. THIS REPORT PERTAINS TO THE AUTOPULSE RESUSCITATION SYSTEM. THREE BATTERIES INVOLVED IN THIS CASE ARE DISCUSSED IN REPORT #3003793491-2012-00274.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 AUTOPULSE RESUSCITATION SYSTEM MODEL 100 CARDIAC CHEST COMPRESSOR DRM ZOLL CIRCULATION, INC 100

    Patients

    Seq Age Sex Outcome Treatment
    1 88 YR Other