BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AUTOPULSE® RESUSCITATION SYSTEM MODEL 100

    MDR report key: 3913724 · Received July 3, 2014

    Report

    Report Number
    3003793491-2014-00319
    Event Type
    Malfunction
    Date Received
    July 3, 2014
    Date of Event
    June 11, 2014
    Report Date
    June 11, 2014
    Manufacturer
    ZOLL CIRCULATION, INC
    Product Code
    DRM
    PMA / PMN Number
    K112998
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NV, US
    Reporter Occupation
    HEALTH 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 (S/N (B)(4)) WAS RETURNED TO THE MANUFACTURER FOR ANALYSIS. VISUAL INSPECTION OF THE RETURNED PLATFORM SHOWS NO VISIBLE OR PHYSICAL DAMAGE TO THE PLATFORM. A REVIEW OF THE AUTOPULSE ARCHIVE WAS PERFORMED AND THE ARCHIVE DATA SHOWS THAT NO CLINICAL EVENT WITH A PATIENT OCCURRED ON THE REPORTED EVENT DATE OF (B)(6) 2014. FUNCTIONAL TESTING WAS PERFORMED AND THE REPORTED ISSUE WAS REPRODUCED. INSPECTION OF THE CHANNEL DIE CAST CONFIRMED THAT THE LIFEBAND WOULD FALL OUT. IT WAS FOUND THAT THE MACHINED CHANNEL WAS DEFECTIVE. IN ADDITION, THE PLATFORM WAS RUN WITH THE 95% PATIENT TEST FIXTURE WITH GOOD BATTERIES FOR SEVERAL HOURS AND NO FAULTS OR ERRORS WERE OBSERVED. LOAD CELL CHARACTERIZATION TEST WAS ALSO PERFORMED WHICH INDICATED THAT BOTH LOAD CELL MODULES WERE FUNCTIONING WITHIN SPECIFICATION. BASED ON THE INVESTIGATION, THE PART IDENTIFIED FOR REPLACEMENT WAS THE DIE CAST CHANNEL. IN SUMMARY, THE REPORTED COMPLAINT WAS CONFIRMED DURING FUNCTIONAL TESTING. UPON REPLACEMENT OF THE DIE CAST CHANNEL, THE PLATFORM WAS RE-EVALUATED AND THE PLATFORM PASSED ALL TESTING CRITERIA.

    Description of Event or Problem · 1

    COMPLAINANT ALLEGED THAT DURING A SHIFT CHECK, IT WAS OBSERVED THAT WHEN LIFEBANDS WERE INSERTED INTO THE AUTOPULSE® PLATFORM, THEY WOULD NOT STAY CONNECTED AND WOULD FALL OFF FROM THE BOTTOM OF THE PLATFORM. WHEN TESTING THE SAME THE LIFEBANDS ON OTHER PLATFORMS, THEY WOULD STAY ATTACHED. THERE WAS NO REPORT OF ANY PATIENT INVOLVEMENT. NO FURTHER DETAILS WERE PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    389680 AUTOPULSE® RESUSCITATION SYSTEM MODEL 100 CARDIAC CHEST COMPRESSOR DRM ZOLL CIRCULATION, INC MODEL 100

    Patients

    Seq Age Sex Outcome Treatment
    1