BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AUTOPULSE® RESUSCITATION SYSTEM MODEL 100

    MDR report key: 4103527 · Received September 19, 2014

    Report

    Report Number
    3010617000-2014-00473
    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
    KS, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT IN COMPLAINT WAS RETURNED TO ZOLL 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 THE MANUFACTURER FOR EVALUATION. VISUAL INSPECTION OF THE RETURNED PLATFORM WAS PERFORMED AND NO PHYSICAL DAMAGES WERE OBSERVED. THE RETURNED PLATFORM WAS UNABLE TO UNDERGO INITIAL FUNCTIONAL TESTING, AS IT EXHIBITED A UA 34 (ENCODER FAILURE) UPON POWER UP. A REVIEW OF THE ARCHIVE WAS PERFORMED AND IT WAS FOUND THAT MULTIPLE UA 34 ERRORS OCCURRED ON THE REPORTED EVENT DATE OF (B)(6) 2014. THE PROCESSOR BOARD WAS REPLACED TO REMEDY THE REPORTED COMPLAINT. THE SYSTEM UNDERWENT AND PASSED ALL FINAL FUNCTIONAL TESTING. THE CUSTOMER'S REPORTED COMPLAINT OF THE PLATFORM EXHIBITING A UA 34 WAS CONFIRMED THROUGH BOTH INITIAL FUNCTIONAL TESTING (AS A UA34 WAS EXHIBITED AS SOON THE PLATFORM WAS POWERED ON) AND REVIEW OF THE PLATFORM ARCHIVE. THE ROOT CAUSE WAS DETERMINED TO BE DUE TO A DEFECTIVE PROCESSOR BOARD, WHICH WAS REPLACED, REMEDYING THE UA34.

    Description of Event or Problem · 1

    COMPLAINANT ALLEGED THAT DURING A SHIFT CHECK, THE AUTOPULSE® PLATFORM DISPLAYED A USER ADVISORY (UA) 34 (ENCODER FAILURE) MESSAGE UPON POWER UP. THERE WAS NO REPORT OF ANY PATIENT INVOLVEMENT. NO ADDITIONAL DETAILS WERE PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    584460 AUTOPULSE® RESUSCITATION SYSTEM MODEL 100 CARDIAC CHEST COMPRESSOR DRM ZOLL CIRCULATION, INC MODEL 100

    Patients

    Seq Age Sex Outcome Treatment
    1