BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AUTOPULSE RESUSCITATION SYSTEM MODEL 100

    MDR report key: 2881782 · Received November 7, 2012

    Report

    Report Number
    3003793491-2012-00255
    Event Type
    Malfunction
    Date Received
    November 7, 2012
    Date of Event
    October 4, 2012
    Report Date
    October 8, 2012
    Manufacturer
    ZOLL CIRCULATION, INC
    Product Code
    DRM
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE REPORTED COMPLAINT OF "UNIT MADE A FEW COMPRESSIONS AND STOPPED" WAS NOT CONFIRMED. BASED ON THE DATE OF OCCURRENCE ((B)(6) 2012), THE SESSIONS THAT PERTAIN TO THE REPORTED INCIDENT ARE THE SESSIONS FROM (B)(6) 2012. USER ADVISORY 2 (COMPRESSION TRACKING ERROR) WAS LOGGED INTO THE ARCHIVE FILE DURING THESE SESSIONS. USER ADVISORY 2 IS GENERATED IF THE LOAD IS VERY LIGHT, OR IF IT IS NOT POSITIONED CORRECTLY. THE BOARD WAS RUN WITH A MANIKIN AND TEST BATTERY, AND THEN RUN WITH THE LARGE RESUSCITATION TEST FIXTURE (EQUIVALENT TO A 250 POUND PT), NO PROBLEMS WERE OBSERVED. NO ADVERSE EVENT REPORTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE UNIT MADE A FEW COMPRESSIONS AND STOPPED. MEDICS TRIED TO SWAP THE BATTERY BUT TO NO IMPROVEMENT. MANUAL CPR WAS ADMINISTERED. NO ADVERSE EVENT REPORTED.

    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