BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AUTOPULSE® RESUSCITATION SYSTEM MODEL 100

    MDR report key: 3735070 · Received April 8, 2014

    Report

    Report Number
    3003793491-2014-00183
    Event Type
    Malfunction
    Date Received
    April 8, 2014
    Date of Event
    March 14, 2014
    Report Date
    March 17, 2014
    Manufacturer
    ZOLL CIRCULATION, INC
    Product Code
    DRM
    PMA / PMN Number
    K112998
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT IN COMPLAINT WAS RETURNED TO ZOLL CIRCULATION ON (B)(4) 2014 FOR INVESTIGATION. HOWEVER, INVESTIGATION IS STILL IN PROGRESS. A SUPPLEMENTAL REPORT WILL BE FILED ONCE INVESTIGATION HAS BEEN COMPLETED.

    Additional Manufacturer Narrative · 1

    THE AUTOPULSE PLATFORM (S/N (B)(4)) WAS RETURNED TO MANUFACTURER FOR ANALYSIS. VISUAL INSPECTION OF THE RETURNED PLATFORM SHOWS THAT THE TOP COVER AND THE FRONT ENCLOSURE WERE CRACKED. THE PHYSICAL DAMAGES FOUND DURING VISUAL INSPECTION ARE NOT RELATED TO THE REPORTED ISSUE THAT THE LIFEBAND WOULD NOT STAY IN THE PLATFORM. THE DAMAGES APPEAR TO HAVE BEEN CAUSED BY NORMAL WEAR AND TEAR (AUTOPULSE MANUFACTURED IN 10/2011). A REVIEW OF THE ARCHIVE DATA WAS PERFORMED AND NO PROBLEMS WERE FOUND. FUNCTIONAL TESTING WAS PERFORMED AND THE REPORTED ISSUE THAT THE LIFEBAND WOULD NOT STAY IN THE PLATFORM WAS VERIFIED. IT WAS FOUND THAT THE CHANNEL DIE CAST WAS AT FAULT. BASED ON THE INVESTIGATION, THE PARTS IDENTIFIED FOR REPLACEMENT ARE THE DIE CAST CHANNEL, TOP COVER, AND THE FRONT ENCLOSURE. IN SUMMARY, THE REPORTED COMPLAINT THAT THE LIFEBAND WOULD NOT STAY IN THE PLATFORM WAS CONFIRMED DURING FUNCTIONAL TESTING. THE FAULT WAS FOUND TO BE DUE TO THE DEFECTIVE DIE CAST CHANNEL. THE PHYSICAL DAMAGES FOUND DURING VISUAL INSPECTION ARE UNRELATED TO THE REPORTED COMPLAINT. UPON REPLACEMENT OF THE DIE CAST CHANNEL AND THE DAMAGED PARTS, THE PLATFORM PASSED ALL TESTING CRITERIA.

    Description of Event or Problem · 1

    COMPLAINANT ALLEGED THAT DURING TRAINING, IT WAS OBSERVED THAT THE AUTOPULSE® LIFEBAND WOULD NOT STAY IN PLACE ON THE AUTOPULSE. CUSTOMER ATTEMPTED TO USE OTHER LIFEBANDS, HOWEVER, THESE WOULD NOT STAY IN PLACE EITHER. THERE WAS NO REPORT OF ANY PATIENT INVOLVEMENT. NO FURTHER DETAILS WERE PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    212596 AUTOPULSE® RESUSCITATION SYSTEM MODEL 100 CARDIAC CHEST COMPRESSOR DRM ZOLL CIRCULATION, INC MODEL 100

    Patients

    Seq Age Sex Outcome Treatment
    1