BEUDAMED
    FDA Adverse Event Death Summary report: N

    AUTOPULSE RESUSCITATION SYSTEM MODEL 100

    MDR report key: 3098807 · Received April 29, 2013

    Report

    Report Number
    3003793491-2013-00485
    Event Type
    Death
    Date Received
    April 29, 2013
    Date of Event
    March 27, 2013
    Report Date
    April 1, 2013
    Manufacturer
    ZOLL CIRCULATION, INC.
    Product Code
    DRM
    PMA / PMN Number
    K112998
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    ZOLL MEDICAL CORPORATION HAS RECEIVED THE PRODUCT AND WILL PROVIDE A SUPPLEMENTAL REPORT WHEN OUR INVESTIGATION IS COMPLETE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A CODE AND AFTER EXAM AT THE HOSPITAL, THE PT WAS OBSERVED TO HAVE TEN BROKEN RIBS. IT WAS REPORTED THAT MANUAL CPR WAS PERFORMED PRIOR TO USING THE AUTOPULSE. ADD'L INFO WAS RECEIVED ON (B)(4), 2013 FROM (B)(6). HE INDICATED THAT IT IS UNK IF THE FRACTURES WERE SUSTAINED BY MANUAL CPR OR THE AUTOPULSE. BASED ON THE TIME, THE CALL WAS RECEIVED TO THE TIME THEY HAD PT CONTACT, MANUAL CPR WAS PERFORMED FOR APPROX 12 TO 14 MINUTES. CPR WAS PERFORMED BY NURSING HOME STAFF AND THE RATE OF COMPRESSIONS WAS NOT KNOWN. THE AUTOPULSE WAS USED FROM FOR APPROX 20 MINUTES OF USE. REVIEW OF THE PT CHART DID NOT INDICATE THAT HE HAD OSTEOPOROSIS. THE PT WAS ON NUMEROUS MEDICATIONS. THE (B)(6) REPORTED THAT THE X-RAY THAT THE HOSPITAL SHOWED WAS VERY DIFFICULT TO SEE. HE INDICATED THAT THERE WERE ENOUGH FRACTURES THAT IT CREATED A FLAIL SEGMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    184979 AUTOPULSE RESUSCITATION SYSTEM MODEL 100 CARDIAC CHEST COMPRESSOR DRM ZOLL CIRCULATION, INC. 100 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 81 YR Death