BEUDAMED
    FDA Adverse Event Death Summary report: N

    AUTOPULSE RESUSCITATION SYSTEM

    MDR report key: 2319611 · Received October 26, 2011

    Report

    Report Number
    3003793491-2011-00006
    Event Type
    Death
    Date Received
    October 26, 2011
    Date of Event
    July 21, 2011
    Report Date
    October 21, 2011
    Manufacturer
    ZOLL CIRCULATION
    Product Code
    DRM
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE WILL NOT BE RETURNED FOR EVAL. IT WAS DETERMINED THAT MANUAL CPR WAS PERFORMED FOR AN UNK PERIOD OF TIME BY THE PT'S GRANDCHILD PRIOR TO DEPLOYMENT OF THE AUTOPULSE SYSTEM. THE AUTOPULSE WAS USED ON THE PT FOR 19 MINUTES. THE CAUSE OF DEATH IS UNK BUT NOT RELATED TO CPR INJURY. THE PRIMARY REASONS FOR SUCH FRACTURES DURING CPR INCLUDE CHEST ELASTICITY, BONE DENSITY, AND ANATOMY OF THE RIB CAGE (KYPHOSCOLOSIS). THE OBSERVED FRACTURES (RIB AND/OR STERNUM) ARE POSSIBLE COMPLICATIONS WITH MANUAL AS WELL AS MECHANICAL CPR. SINCE MANUAL CPR WAS PERFORMED PRIOR TO DEPLOYMENT OF THE AUTOPULSE, IT IS NOT POSSIBLE TO IDENTIFY WHICH OF THE TWO CPR METHODS MAY HAVE CAUSED THE SUSPECTED FRACTURE. CPR INJURIES ARE OF RELATIVE SIGNIFICANCE GIVEN THE ALTERNATIVE OF DEATH. (B)(6).

    Description of Event or Problem · 1

    AN EVENT WAS RECEIVED FROM A CUSTOMER CLAIMING THAT A PT HAS PASSED AWAY AND HER RIBS WERE FRACTURED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 AUTOPULSE RESUSCITATION SYSTEM AUTOPULSE CHEST COMPRESSION DRM ZOLL CIRCULATION 105 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 87 YR Death