BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AUTOPULSE® RESUSCITATION SYSTEM MODEL 100

    MDR report key: 3841871 · Received May 30, 2014

    Report

    Report Number
    3003793491-2014-00267
    Event Type
    Malfunction
    Date Received
    May 30, 2014
    Date of Event
    May 5, 2014
    Report Date
    May 6, 2014
    Manufacturer
    ZOLL CIRCULATION, INC
    Product Code
    DRM
    PMA / PMN Number
    K112998
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    IT WAS ALSO REPORTED THAT DURING AN ONSITE TRAINING WITH THE CUSTOMER, THE AUTOPULSE DEPLOYMENT SPECIALIST OBSERVED THAT WHEN THE AUTOPULSE WAS DEPLOYED, THE INCORRECT PINS FOR THE SHOULDER STRAPS WERE BEING USED. FOR INSTANCE, THE YELLOW STRAP WAS CONNECTED TO THE LOWER PINS, NOT AT THE CORRECT PLACEMENT OF THE YELLOW LINES. IT WAS ALSO OBSERVED THAT THE CHEST STRAP WAS BEING TIGHTENED TOO TIGHT. IT IS UNKNOWN HOW THE STRAP WAS UTILIZED DURING THIS INCIDENT. PRODUCT IN COMPLAINT WILL NOT BE RETURNED. THEREFORE, PHYSICAL INVESTIGATION CANNOT BE PERFORMED. A SUPPLEMENTAL REPORT WILL BE FILED IF THE PRODUCT IN COMPLAINT IS RETURNED AND INVESTIGATION IS COMPLETED.

    Description of Event or Problem · 1

    COMPLAINANT ALLEGED THAT DURING PATIENT USE, THE AUTOPULSE® PLATFORM PERFORMED THREE COMPRESSIONS AND THEN STOPPED. NO ADVERSE PATIENT SEQUELAE WAS REPORTED. NO FURTHER DETAILS WERE PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    319681 AUTOPULSE® RESUSCITATION SYSTEM MODEL 100 CARDIAC CHEST COMPRESSOR DRM ZOLL CIRCULATION, INC MODEL 100

    Patients

    Seq Age Sex Outcome Treatment
    1