BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AUTOPULSE® RESUSCITATION SYSTEM MODEL 100

    MDR report key: 3873093 · Received June 13, 2014

    Report

    Report Number
    3003793491-2014-00282
    Event Type
    Malfunction
    Date Received
    June 13, 2014
    Date of Event
    May 20, 2014
    Report Date
    May 20, 2014
    Manufacturer
    ZOLL CIRCULATION, INC
    Product Code
    DRM
    PMA / PMN Number
    K112998
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    ZOLL HAS NOT YET RECEIVED THE PRODUCT IN COMPLAINT FOR INVESTIGATION. A SUPPLEMENTAL REPORT WILL BE FILED IF AND WHEN THE PRODUCT IS RETURNED AND INVESTIGATION HAS BEEN COMPLETED.

    Additional Manufacturer Narrative · 1

    INITIAL FUNCTIONAL TESTING INDICATED THAT THE REPORTED COMPLAINT COULD NOT BE CONFIRMED AND THE PLATFORM RAN FINE WITH A TEST MANNEQUIN AND LRTF. ADDITIONAL TESTING WAS PERFORMED AND FOUND THAT THE LIFEBAND WAS LOOSE, RESULTING IN THE LIFEBAND FALLING OFF FROM THE PLATFORM. IT WAS FOUND THAT THE CHANNEL DIE CAST WAS AT FAULT. LOAD CELL CHARACTERIZATION TESTING WAS ALSO PERFORMED, WHICH REVEALED THAT BOTH LOAD CELLS WERE FUNCTIONING AS INTENDED. BASED ON FURTHER INVESTIGATION, THE PARTS IDENTIFIED FOR REPLACEMENT WERE THE FRONT ENCLOSURE AND THE CHANNEL DIE CAST ASSEMBLY. IN SUMMARY, THE LOOSE LIFEBAND ISSUE THAT WAS OBSERVED DURING ADDITIONAL FUNCTIONAL TESTING IS UNRELATED TO THE REPORTED COMPLAINT. THE FAULT WAS FOUND TO BE DUE TO THE DEFECTIVE CHANNEL DIE CAST. UPON REPLACEMENT OF ALL PARTS, THE PLATFORM WAS RE-EVALUATED THROUGH FUNCTIONAL TESTING AND THE PLATFORM PASSED ALL TESTING CRITERIA.

    Additional Manufacturer Narrative · 1

    THE AUTOPULSE PLATFORM (S/N (B)(4)) WAS RETURNED TO THE MANUFACTURER FOR ANALYSIS. VISUAL INSPECTION OF THE RETURNED PLATFORM SHOWS THAT THE FRONT ENCLOSURE WAS CRACKED. THE PHYSICAL DAMAGE FOUND DURING VISUAL INSPECTION IS NOT RELATED TO THE REPORTED EVENT OF THE PLATFORM STOPPING COMPRESSIONS, TURNING OFF OR DISPLAYING ERROR MESSAGES. THE DAMAGE APPEARS TO HAVE BEEN CAUSED BY NORMAL WEAR AND TEAR (AUTOPULSE MANUFACTURED IN 12/2011). A REVIEW OF THE ARCHIVE WAS PERFORMED AND THE REPORTED COMPLAINT WAS NOT CONFIRMED. THE ARCHIVE DATA SHOWS THAT CLINICAL USE WITH A PATIENT OCCURRED ON THE REPORTED EVENT DATE OF (B)(6) 2014, HOWEVER NO FAULT OR ERROR MESSAGES WERE OBSERVED. FUNCTIONAL TESTING WAS PERFORMED AND THE REPORTED ISSUE WAS NOT CONFIRMED. THE PLATFORM RAN FOR 15 MINUTES WITH A TEST MANNEQUIN AND 7 MINUTES WITH THE LRTF (LARGE RESUSCITATION TEST FIXTURE) AND NO PROBLEMS WERE OBSERVED. BASED ON THE INITIAL INVESTIGATION, THE PART IDENTIFIED FOR REPLACEMENT WAS THE FRONT ENCLOSURE. IN SUMMARY, THE REPORTED COMPLAINT OF THE PLATFORM STOPPING COMPRESSIONS, TURNING OFF OR DISPLAYING ERROR MESSAGES WAS NOT CONFIRMED. THE PLATFORM PASSED FUNCTIONAL TESTING. THE PHYSICAL DAMAGE FOUND DURING VISUAL INSPECTION IS UNRELATED TO THE REPORTED COMPLAINT.

    Description of Event or Problem · 1

    COMPLAINANT ALLEGED THAT THE AUTOPULSE® NEVER WORKED AS IT SHOULD HAVE. COMPLAINANT COULD NOT PROVIDE SPECIFIC DETAILS, BUT INDICATED THAT THERE HAVE BEEN REPORTS OF THE PLATFORM STOPPING COMPRESSIONS, TURNING OFF OR DISPLAYING ERROR MESSAGES. NO ADVERSE PATIENT SEQUELAE WAS REPORTED. NO FURTHER DETAILS WERE PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    349260 AUTOPULSE® RESUSCITATION SYSTEM MODEL 100 CARDIAC CHEST COMPRESSOR DRM ZOLL CIRCULATION, INC MODEL 100

    Patients

    Seq Age Sex Outcome Treatment
    1