BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AUTOPULSE RESUSCITATION SYSTEM MODEL 100

    MDR report key: 2872131 · Received December 5, 2012

    Report

    Report Number
    3003793491-2012-00439
    Event Type
    Injury
    Date Received
    December 5, 2012
    Date of Event
    September 27, 2012
    Report Date
    November 5, 2012
    Manufacturer
    ZOLL CIRCULATION, INC.
    Product Code
    DRM
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    ZOLL MEDICAL CORPORATION HAS NOT RECEIVED THE PRODUCT FOR EVALUATION AND THIS COMPLAINT IS STILL UNDER INVESTIGATION.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE CREWS APPLIED THE DEVICE CORRECTLY WITH NO ERROR MESSAGES AND THE PT HAD SEVERAL RIB FRACTURES ON BOTH SIDES AT THE SAME LOCATIONS.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 Other