BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AUTOPULSE RESUSCITATION SYSTEM MODEL 100

    MDR report key: 3173450 · Received May 28, 2013

    Report

    Report Number
    3003793491-2013-00626
    Event Type
    Malfunction
    Date Received
    May 28, 2013
    Date of Event
    December 25, 2012
    Report Date
    May 6, 2013
    Manufacturer
    ZOLL CIRCULATION, INC.
    Product Code
    DRM
    PMA / PMN Number
    K112998
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE AUTOPULSE PLATFORM WITH SERIAL NUMBER (B)(4) WAS RECEIVED FOR INVESTIGATION ON 5/17/2013 AND THE REPORTED COMPLAINT WAS NOT CONFIRMED. VISUAL INSPECTION WAS PERFORMED AND NO ANOMALIES WERE FOUND. A REVIEW OF THE DATA ARCHIVE INDICATED THAT THE INCIDENT DATE MAY HAVE BEEN (B)(6) 2012. THE INFO RETRIEVED FROM THE ARCHIVE FILES DID NOT MATCH THE REPORTED DESCRIPTION. THE RETURNED AUTOPULSE PASSED FUNCTIONAL TESTING. THE PLATFORM WAS RUN WITH A TEST BATTERY AND MANIKIN FOR 30 MINUTES AND NO PROBLEMS WERE ENCOUNTERED. BASED ON THE EVALUATION RESULTS, A DEFINITIVE ROOT CAUSE FOR THE REPORTED COMPLAINT COULD NOT BE DETERMINED.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT WHILE USING THE AUTOPULSE ON A PT, THE PLATFORM DISPLAYED "ALIGN PATIENT" MESSAGE. THE PLATFORM RAN FOR ABOUT 30 SECONDS. THE USER PRESSED THE DEVICE OFF/ON SWITCH AND THE PLATFORM WORKED AGAIN FOR ONLY 30 SECONDS. THE BATTERY WAS REPLACED HOWEVER THE PROBLEM OCCURRED AGAIN AFTER BEING ON THE PT FOR ABOUT 30 SECONDS. THE CUSTOMER ALSO REPORTED THAT THIS PLATFORM BEHAVED THE SAME WAY DURING TRAINING. THE CUSTOMER WAS NOT SURE IF THIS IS THE PLATFORM OR ANOTHER PLATFORM THEY HAVE THAT WAS HAVING THIS ISSUE SINCE THE EVENT OCCURRED IN (B)(6) 2012. HOWEVER, HE BELIEVES IT IS THIS PLATFORM (S/N (B)(4)) THAT FAILED BECAUSE IT IS THE ONE THAT WAS IN THE AMBULANCE. THE CUSTOMER REPORTED THAT HE DOES NOT BELIEVE THE PLATFORM HAS BEEN USED SINCE THE INCIDENT AND IN TRAINING. NO ADVERSE PT SEQUELAE WERE REPORTED. (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    233342 AUTOPULSE RESUSCITATION SYSTEM MODEL 100 CARDIAC CHEST COMPRESSOR DRM ZOLL CIRCULATION, INC. MODEL 100 NA

    Patients

    Seq Age Sex Outcome Treatment
    1