BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AUTOPULSE RESUSCITATION SYSTEM MODEL 100

    MDR report key: 3150039 · Received May 20, 2013

    Report

    Report Number
    3003793491-2013-00563
    Event Type
    Malfunction
    Date Received
    May 20, 2013
    Date of Event
    April 23, 2013
    Report Date
    April 23, 2013
    Manufacturer
    ZOLL CIRCULATION, INC.
    Product Code
    DRM
    PMA / PMN Number
    K112998
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE AUTOPULSE PLATFORM/BATTERY IN COMPLAINT WAS RETURNED TO ZOLL ON 06/19/2013 FOR INVESTIGATION. INVESTIGATION RESULTS AS FOLLOWS: VISUAL INSPECTION WAS PERFORMED AND CONFIRMED THAT THE LOAD PLATE COVER WAS TORN. A DEFINITIVE CAUSE FOR THIS DAMAGE COULD NOT BE CONFIRMED. DURING VISUAL INSPECTION, IT WAS ALSO DETECTED THAT THE LIFEBAND WILL FALL OFF ONLY WHEN THE DEVICE WAS FLIPPED OVER AND SHAKEN WITH A LOT OF FORCE. BASED ON THIS OBSERVATION, THE REPORTED COMPLAINT WAS CONFIRMED. A REVIEW OF THE ARCHIVE WAS PERFORMED AND NO SIGNIFICANT DISCREPANCIES WERE NOTED. FUNCTIONAL TESTING OF THE PLATFORM WAS PERFORMED AND NO ISSUES WERE NOTED. IN SUMMARY, THE REPORTED ISSUE OF THE LIFEBAND NOT LOCKING FIRMLY ONTO THE PLATFORM WAS CONFIRMED, HOWEVER A DEFINITIVE ROOT CAUSE COULD NOT BE CONFIRMED.

    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.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A SHIFT CHECK, A LIFEBAND WAS INSTALLED ONTO THE AUTOPULSE PLATFORM BUT IT DID NOT LOCK/LATCH ON. CUSTOMER TRIED ANOTHER LIFEBAND FROM A DIFFERENT BOX AND WAS ABLE TO REPLICATE THE REPORTED PROBLEM. NO PATIENT INVOLVEMENT WAS REPORTED AND NO FURTHER INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    221502 AUTOPULSE RESUSCITATION SYSTEM MODEL 100 CARDIAC CHEST COMPRESSOR DRM ZOLL CIRCULATION, INC. MODEL 100 NA

    Patients

    Seq Age Sex Outcome Treatment
    1