BEUDAMED
    FDA Adverse Event Other Summary report: N

    AUTOPULSE RESUSCITATION SYSTEM

    MDR report key: 2171917 · Received March 31, 2007

    Report

    Report Number
    3003793491-2007-00001
    Event Type
    Other
    Date Received
    March 31, 2007
    Date of Event
    February 19, 2007
    Report Date
    March 31, 2007
    Manufacturer
    ZOLL CIRCULATION
    Product Code
    DRM
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    SUBSEQUENT TO THE REPORT FROM (B)(6), ZOLL OBTAINED THE PATHOLOGIST'S REPORT REGARDING AN UNUSUAL PATTERN OF RIB FRACTURES THAT WERE OF SUCH SEVERITY THAT IF THE PT HAD SURVIVED, HE WOULD HAVE HAD A FLAIL CHEST. THE REPORT "EMPHASIZES THAT THE RESUSCITATION HAS NOT CONTRIBUTED TO HIS (PT) DEATH." THIS REPORT IS SUBMITTED BASED ON THE REPORTED INJURIES. HOWEVER, IT IS IMPORTANT TO NOTE THE FOLLOWING STATEMENT RELEASED FROM THE 2005, INTL CONSENSUS CONFERENCE ON CARDIOPULMONARY RESUSCITATION AND EMERGENCY CARDIOVASCULAR CARE SCIENCE "RIB FRACTURES AND OTHER INJURIES ARE COMMON BUT ACCEPTABLE CONSEQUENCES OF CPR GIVEN THE ALTERNATIVE OF DEATH FROM CARDIAC ARREST." THE INJURIES FOUND IN THIS CASE ARE CONSISTENT WITH CPR. ENGINEERING EVAL OF THE DEVICE HAS NOT BEEN CONDUCTED AS YET. IT IS CURRENTLY ENROUTE TO OUR FACILITY FOR EVAL. HOWEVER, NOTHING IN THE REPORTED EVENT WOULD LEAD US TO CONCLUDE THAT THE DEVICE MALFUNCTIONED. FOLLOWING RECEIPT AND EVAL OF THE DEVICE, ZOLL CIRCULATION WILL SUBMIT A FINAL REPORT.

    Description of Event or Problem · 1

    AS REPORTED BY INITIAL REPORTER (B)(6), POST MORTEM OF A PT REVEALED RIB FRACTURES, PATHOLOGIST BELIEVES INJURIES SUSTAINED WERE CONSISTENT WITH THE USE OF THE AUTOPULSE. MANUAL CPR WAS APPLIED PRIOR TO THE APPLICATION OF THE AUTOPULSE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 AUTOPULSE RESUSCITATION SYSTEM AUTOMATED CHEST COMPRESSOR DRM ZOLL CIRCULATION 100 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 37 YR Other