BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AUTOPULSE RESUSCITATION SYSTEM MODEL 100

    MDR report key: 3087540 · Received April 9, 2013

    Report

    Report Number
    3003793491-2013-00443
    Event Type
    Malfunction
    Date Received
    April 9, 2013
    Date of Event
    March 8, 2013
    Report Date
    March 19, 2013
    Manufacturer
    ZOLL CIRCULATION, INC
    Product Code
    DRM
    PMA / PMN Number
    K112998
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    ZOLL MEDICAL CORP HAS RECEIVED 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

    IT WAS REPORTED THAT THE EMERGENCY CREW PAUSED THE PLATFORM FOR AIRWAY PLACEMENT, BUT AFTERWARDS, THE UNIT WOULD NOT RESTART. USER ADVISORY 7 (DISCREPANCY BETWEEN LOAD 1 AND LOAD 2 TOO LARGE) WAS INDICATED. EMERGENCY CREW REPOSITIONED THE PT, REMOVED THE BATTERY, LIFTED THE BAND, BUT TO NO AVAIL. MANUAL CPR HAD BEEN ADMINISTERED BEFORE AND AFTER THE USE OF THE AUTOPULSE PLATFORM. THE PT WAS A (B)(6) FEMALE THAT HAD AN EXTENSIVE CARDIAC HX AND DID NOT SURVIVE. THE REPORTER INDICATED THAT THERE WAS LIMITED INFO AND THE PRESUMED CAUSE OF DEATH WAS CARDIAC.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    146822 AUTOPULSE RESUSCITATION SYSTEM MODEL 100 CARDIAC CHEST COMPRESSOR DRM ZOLL CIRCULATION, INC 100 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 Other MANUAL COMPRESSION