BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AUTOPULSE¿ RESUSCITATION SYSTEM MODEL 100

    MDR report key: 3260380 · Received August 1, 2013

    Report

    Report Number
    3003793491-2013-00765
    Event Type
    Malfunction
    Date Received
    August 1, 2013
    Date of Event
    July 10, 2013
    Report Date
    July 10, 2013
    Manufacturer
    ZOLL CIRCULATION, INC
    Product Code
    DRM
    PMA / PMN Number
    K112998
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    ZOLL HAS NOT RECEIVED THE PRODUCT IN COMPLAINT. A SUPPLEMENTAL REPORT WILL BE FILED IF AND WHEN THE PRODUCT IS RETURNED AND INVESTIGATION HAS BEEN PERFORMED.

    Additional Manufacturer Narrative · 1

    THE AUTOPULSE PLATFORM/BATTERY IN COMPLAINT WAS RETURNED TO ZOLL ON (B)(4) 2013 FOR INVESTIGATION. INVESTIGATION RESULTS AS FOLLOWS: VISUAL INSPECTION WAS PERFORMED AND NO DAMAGES WERE OBSERVED. A SYSTEM ERROR WAS OBSERVED AT POWER ON OF THE RETURNED PLATFORM. FUNCTIONAL TESTING COULD NOT BE PERFORMED DUE TO THE OBSERVED SYSTEM ERROR. THE ERROR WAS CLEARED USING THE APVISION3 PROGRAM AND THE PLATFORM PASSED FINAL TESTING. REVIEW OF THE ARCHIVE FILES ALSO INDICATED THAT FAULT 132 (INTERNAL WATCHDOG TIMEOUT) HAD OCCURRED. BASED ON THE EVALUATION RESULTS, THE CUSTOMER'S REPORTED COMPLAINT WAS CONFIRMED. HOWEVER, A DEFINITIVE ROOT CAUSE COULD NOT BE DETERMINED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A MORNING CHECK, THE AUTOPULSE PLATFORM DISPLAYED A SYSTEM ERROR MESSAGE. NO PATIENT INVOLVEMENT WAS REPORTED. MANUFACTURER REQUESTED ADDITIONAL INFORMATION FROM THE CUSTOMER ON (B)(4) 2013; HOWEVER, NO ADDITIONAL INFORMATION HAS BEEN OBTAINED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    359798 AUTOPULSE¿ RESUSCITATION SYSTEM MODEL 100 CARDIAC CHEST COMPRESSOR DRM ZOLL CIRCULATION, INC MODEL 100

    Patients

    Seq Age Sex Outcome Treatment
    1