BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AUTOPULSE RESUSCITATION SYSTEM MODEL 100

    MDR report key: 2932951 · Received December 31, 2012

    Report

    Report Number
    3003793491-2012-00618
    Event Type
    Malfunction
    Date Received
    December 31, 2012
    Date of Event
    December 6, 2012
    Report Date
    December 6, 2012
    Manufacturer
    ZOLL CIRCULATION, INC.
    Product Code
    DRM
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    COMPLAINT OF "NEW BATTERY ALLOWED PLATFORM TO COMPRESS 3 TIMES WHEN STOPPED" WAS NOT VERIFIED. PLATFORM WAS RUN WITH CUSTOMER'S BATTERY SN (B)(4) FOR 45 MINUTES USING A TEST MANIKIN AND 7 MINUTES WITH LARGE RESUSCITATION TEST FIXTURE, WHICH IS EQUAL TO A 250 POUND PATIENT WITH NO ISSUES. HOWEVER, BASED ON THE ARCHIVE FILE, BATTERY SN (B)(4) WAS NOT INVOLVED IN THE REPORTED INCIDENT. ARCHIVE FILE SHOWS THAT ON THE DATE OF THE EVENT, ONLY ONE BATTERY, SN (B)(4), WAS USED AND THAT THE BATTERY VOLTAGE WAS LOW, THEREFORE, PLATFORM RAN FOR 86 COMPRESSIONS AND STOPPED. NO ADVERSE EVENT REPORTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PLATFORM COMPRESSED 3 TIMES WITH A NEW BATTERY THEN STOPPED. A SPARE BATTERY WAS USED WITH SAME RESULTS. THIS EVENT WAS EXPERIENCED ON A (B)(6) PATIENT. MANUAL CPR WAS PERFORMED AND THERE WAS NO ADVERSE EFFECT TO THE PATIENT.

    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 Other