BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AUTOPULSE RESUSCITATION SYSTEM MODEL 100

    MDR report key: 3001796 · Received December 21, 2012

    Report

    Report Number
    3003793491-2012-00717
    Event Type
    Malfunction
    Date Received
    December 21, 2012
    Date of Event
    October 9, 2012
    Report Date
    October 9, 2012
    Manufacturer
    ZOLL CIRCULATION, INC.
    Product Code
    DRM
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE AUTOPULSE DEVICE (S/N (B)(4)) INVOLVED IN THE EVENT WAS RETURNED TO ZOLL CIRCULATION ON (B)(4) 2012 AND WAS ANALYZED. VISUAL INSPECTION OF THE AUTOPULSE SHOWED THE PATIENT HEAD RESTRAINT WIRE OF THE TOP COVER WAS CUT. IN ADDITION, IT ALSO SHOWED TWISTED BATTERY CLIP AND CRACKED ENCODER COVER. THE TOP COVER, BATTERY CLIP, AND THE ENCODER COVER WERE REPLACED. THE REPORTED PROBLEM WAS CONFIRMED. THE ARCHIVE DATA SHOW MULTIPLE UA02 (COMPRESSION TRACKING ERROR). FURTHERMORE, THE LOAD CELL CHARACTERIZATION TESTING CONFIRMED THAT THE LOAD CELL MODULE WAS NOT FUNCTIONING PROPERLY. THE LOAD CELL MODULE WAS REPLACED AND THE DEVICE PASSED FINAL TESTING. NO ADVERSE EVENT WAS REPORTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT INTERMITTENTLY, THE BOARD WILL NOT TAKE UP THE LIFEBAND COMPLETELY TO SIZE UP THE PATIENT AND BEGIN COMPRESSIONS. WHEN THIS HAPPENS, UA02 (COMPRESSION TRACKING ERROR) APPEARS. THE BOARD WILL NOT CONTINUE UNLESS IS SHUT OFF AND THEN RESTARTED. SOMETIMES THIS WILL WORK AND THE BOARD WILL OPERATE, OTHER TIMES IT WILL DEFAULT DOING THE SAME THING AS DESCRIBED AND NOT OPERATE AT ALL.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 Other