BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AUTOPULSE® RESUSCITATION SYSTEM MODEL 100

    MDR report key: 4103461 · Received September 19, 2014

    Report

    Report Number
    3010617000-2014-00474
    Event Type
    Malfunction
    Date Received
    September 19, 2014
    Date of Event
    August 26, 2014
    Report Date
    August 26, 2014
    Manufacturer
    ZOLL CIRCULATION, INC
    Product Code
    DRM
    PMA / PMN Number
    K112998
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    ZOLL 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 EVALUATION. VISUAL INSPECTION OF THE RETURNED PLATFORM WAS PERFORMED, WHICH FOUND THAT THE ENCODER COVER AND PATIENT HEAD RESTRAINT BRACKET WERE DAMAGED. THE RETURNED PLATFORM WAS UNABLE TO UNDERGO INITIAL FUNCTIONAL TESTING AS IT DISPLAYED A "SYSTEM ERROR, OUT OF SERVICE, REVERT TO MANUAL CPR" MESSAGE, UPON POWER UP. NO PARTS NEEDED TO BE REPLACED TO REMEDY THE REPORTED COMPLAINT, HOWEVER THE SYSTEM ERROR WAS CLEARED. ADDITIONAL WORK COMPLETED NOT RELATED TO THE REPORTED COMPLAINT TO ENSURE THAT THE AUTOPULSE PLATFORM IS FUNCTIONING WITHOUT ISSUE: THE ENCODER COVER AND PATIENT HEAD RESTRAINT BRACKET WERE BOTH REPLACED. THE CUSTOMER'S REPORTED COMPLAINT THAT THE PLATFORM DISPLAYED A "SYSTEM ERROR, OUT OF SERVICE, REVERT TO MANUAL CPR" MESSAGE WAS CONFIRMED THROUGH INITIAL FUNCTIONAL TESTING. THE ROOT CAUSE WAS UNABLE TO BE DETERMINED. THE PLATFORM UNDERWENT AND PASSED ALL FINAL FUNCTIONAL TESTING.

    Description of Event or Problem · 1

    COMPLAINANT ALLEGED THAT DURING A SHIFT CHECK, THE AUTOPULSE® PLATFORM DISPLAYED A "SYSTEM ERROR-OUT OF SERVICE" MESSAGE THAT WAS UNABLE TO BE CLEARED BY POWERING THE DEVICE OFF AND ON. THERE WAS NO REPORT OF ANY PATIENT INVOLVEMENT. NO FURTHER DETAILS WERE PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    584689 AUTOPULSE® RESUSCITATION SYSTEM MODEL 100 CARDIAC CHEST COMPRESSOR DRM ZOLL CIRCULATION, INC MODEL 100

    Patients

    Seq Age Sex Outcome Treatment
    1