BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AUTOPULSE? RESUSCITATION SYSTEM MODEL 100

    MDR report key: 3191771 · Received June 26, 2013

    Report

    Report Number
    3003793491-2013-00714
    Event Type
    Malfunction
    Date Received
    June 26, 2013
    Date of Event
    December 25, 2012
    Report Date
    June 5, 2013
    Manufacturer
    ZOLL CIRCULATION, INC
    Product Code
    DRM
    PMA / PMN Number
    K112998
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OR, US
    Reporter Occupation
    EMERGENCY MEDICAL TECHNICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE AUTOPULSE PLATFORM (S/N (B)(4)) INVOLVED IN THE EVENT WAS RETURNED FOR EVALUATION. VISUAL INSPECTION OF THE RETURNED AUTOPULSE PLATFORM SHOWED NO PHYSICAL DAMAGES. REVIEW OF THE AUTOPULSE ARCHIVE DATA SHOWED NUMEROUS USER ADVISORY 2 (COMPRESSION TRACKING ERROR), USER ADVISORY 8 (MOTOR CONTROLLER FAULT DETECTED) AND USER ADVISORY 17 (MAX MOTOR ON TIME EXCEEDED DURING ACTIVE OPERATION) FAULTS. REVIEW OF THE ARCHIVE DATA DOES NOT INDICATE ANY FAULTS OR ERROR MESSAGES OCCURRING IN (B)(6) 2012. THERE WAS ONE INSTANCE NOTED IN (B)(6) 2012 WHERE COMPRESSIONS WERE PERFORMED, HOWEVER, NO PROBLEMS WERE OBSERVED. FUNCTIONAL TESTING WAS PERFORMED WITH THE RETURNED AUTOPULSE BOARD USING A TEST BATTERY, AND THE UNIT RAN SUCCESSFULLY FOR 30 MINUTES, WITH NO PROBLEMS. IN SUMMARY, REVIEW OF THE ARCHIVE DATA AS WELL FUNCTIONAL TESTING USING A TEST BATTERY, COULD NOT CONFIRM THE REPORTED COMPLAINT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE AUTOPULSE RESUSCITATION SYSTEM DISPLAYED AN "ALIGN PATIENT" MESSAGE WHILE IN USE WITH A PATIENT AND RAN FOR ONLY ABOUT 30 SECONDS. DEVICE WAS TURNED OFF/ON AND WORKED AGAIN FOR ONLY 30 SECONDS. THE BATTERY WAS REPLACED AND THE PROBLEM RECURRED AFTER BEING ON THE PATIENT FOR APPROXIMATELY 30 SECONDS. CUSTOMER INDICATED THAT THE PLATFORM ALSO BEHAVED THE SAME WAY DURING TRAINING. THE PROBLEM WITH THE PATIENT HAPPENED LAST DECEMBER AND CUSTOMER DOES NOT BELIEVE THE BOARD HAS BEEN USED SINCE THE INCIDENT AND/OR DURING TRAINING. NO ADVERSE PATIENT SEQUELAE WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    290976 AUTOPULSE? RESUSCITATION SYSTEM MODEL 100 CARDIAC CHEST COMPRESSOR DRM ZOLL CIRCULATION, INC MODEL 100

    Patients

    Seq Age Sex Outcome Treatment
    1