BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AUTOPULSE RESUSCITATION SYSTEM MODEL 100

    MDR report key: 3150037 · Received May 20, 2013

    Report

    Report Number
    3003793491-2013-00581
    Event Type
    Malfunction
    Date Received
    May 20, 2013
    Date of Event
    April 26, 2013
    Report Date
    April 26, 2013
    Manufacturer
    ZOLL CIRCULATION, INC.
    Product Code
    DRM
    PMA / PMN Number
    K112998
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    ZOLL CIRCULATION 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 IN COMPLAINT WAS RETURNED TO ZOLL ON (B)(6) 2013 FOR INVESTIGATION. INVESTIGATION RESULTS AS FOLLOWS: VISUAL INSPECTION WAS PERFORMED AND CONFIRMED THE LOAD PLATE COVER WAS TORN. A DEFINITIVE ROOT CAUSE FOR THIS PHYSICAL DAMAGE COULD NOT BE DETERMINED. FUNCTIONAL TESTING WAS PERFORMED AND CONFIRMED A LOUD GRINDING TYPE NOISE OCCURRED WHEN THE BELT CONTRACTS. FURTHER INSPECTION OF THE PLATFORM CONFIRMED THAT THIS WAS LIKELY DUE TO A DEFECTIVE DRIVETRAIN; HOWEVER A ROOT CAUSE FOR THIS FAILED COMPONENT COULD NOT BE DETERMINED BASED ON THE EVALUATION RESULTS. A REVIEW OF THE ARCHIVE WAS ALSO PERFORMED AND CONFIRMED MULTIPLE USER ADVISORY FAULT 16 (TIMEOUT MOVING TO TAKE-UP POSITION) AND USER ADVISORY 24 (TIMEOUT MOVING TO HOME POSITION) FAULTS IN THE MOST RECENT ARCHIVE SESSIONS. BASED ON THE REVIEW OF THE ARCHIVE, THE REPORTED COMPLAINT OF MULTIPLE LOW RUN TIMES AND USER ADVISORY CODES WAS CONFIRMED. A DEFINITIVE CAUSE FOR THESE OBSERVED FAULTS COULD NOT BE DETERMINED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE AUTOPULSE PLATFORM HAS BEEN TAKEN OUT OF SERVICE DUE TO MULTIPLE REPORTS OF LOW RUN TIMES AND USER ADVISORY (UA) ERROR CODES. CUSTOMER DOES NOT RECALL EXACTLY WITH ERROR CODES. NO ADVERSE PATIENT SEQUELAE WAS REPORTED. NO FURTHER INFORMATION PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    221555 AUTOPULSE RESUSCITATION SYSTEM MODEL 100 CARDIAC CHEST COMPRESSOR DRM ZOLL CIRCULATION, INC. MODEL 100 NA

    Patients

    Seq Age Sex Outcome Treatment
    1