BEUDAMED
    FDA Adverse Event Death Summary report: N

    AUTOPULSE RESUSCITAITON SYSTEM MODEL 100

    MDR report key: 3130990 · Received May 13, 2013

    Report

    Report Number
    3003793491-2013-00545
    Event Type
    Death
    Date Received
    May 13, 2013
    Date of Event
    April 12, 2013
    Report Date
    April 16, 2013
    Manufacturer
    ZOLL CIRCULATION, INC.
    Product Code
    DRM
    PMA / PMN Number
    K112998
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    ZOLL MEDICAL CORPORATION HAS REC'D THE DEVICE ASSOCIATED WITH THIS REPORT; HOWEVER, THE DEVICE IS STILL UNDER INVESTIGATION. A SUPPLEMENTAL REPORT WILL BE SUBMITTED WHEN THE INVESTIGATION IS COMPLETE.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT THE AUTOPULSE PLATFORM WAS USED ON A (B)(6) MALE PT BEING TREATED FOR CARDIO PULMONARY ARREST. UPON POWER UP, THE BOARD WORKED FOR SEVERAL MINUTES AND AN ERROR MESSAGE OCCURRED ON THE SCREEN. THE PLATFORM KEPT ON SHOWING REPLACED LIFEBAND. THE MEDIC HAD TO REVERT BACK TO MANUAL CPR. THE PT EXPIRED. THE EXACT DATE AND CAUSE OF DEATH WAS NOT PROVIDED. AFTER THE INCIDENT, NEW LIFEBAND WAS REPLACED. THEY USED THE PLATFORM ON A MANIKIN AND THE SAME PROBLEM OCCURRED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    211670 AUTOPULSE RESUSCITAITON SYSTEM MODEL 100 CARDIAC CHEST COMPRESSOR DRM ZOLL CIRCULATION, INC. MODEL 100 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 72 YR Death MANUAL COMPRESSION