BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AUTOPULSE® RESUSCITATION MODEL 100

    MDR report key: 4221381 · Received November 3, 2014

    Report

    Report Number
    3010617000-2014-00586
    Event Type
    Malfunction
    Date Received
    November 3, 2014
    Date of Event
    October 6, 2014
    Report Date
    October 9, 2014
    Manufacturer
    ZOLL CIRCULATION
    Product Code
    DRM
    PMA / PMN Number
    K112998
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE AUTOPULSE PLATFORM S/N (B)(4) WAS RETURNED TO ZOLL (B)(4) FOR EVALUATION. VISUAL INSPECTION OF THE RETURNED PLATFORM WAS PERFORMED AND FOUND NO DAMAGE TO THE PLATFORM. THE RETURNED PLATFORM WAS UNABLE TO UNDERGO INITIAL FUNCTIONAL TESTING, AS IT DISPLAYED A "SYSTEM ERROR, OUT OF SERVICE, REVERT TO MANUAL CPR" MESSAGE. A REVIEW OF THE ARCHIVE WAS PERFORMED AND NO ANOMALIES WERE FOUND ON THE REPORTED EVENT DATE OF (B)(6) 2014. THE SYSTEM PROCESSOR BOARD WAS REPLACED TO REMEDY THE REPORTED COMPLAINT. FOLLOWING REPLACEMENT OF THE SYSTEM PROCESSOR BOARD, THE PLATFORM UNDERWENT AND PASSED ALL FINAL FUNCTIONAL TESTING.

    Additional Manufacturer Narrative · 1

    THE AUTOPULSE PLATFORM IN COMPLAINT WAS RETURNED TO ZOLL (B)(4) FOR INVESTIGATION. ZOLL (B)(4) CONFIRMED THE REPORTED EVENT WITH A SYSTEM ERROR CODE 132 (INTERNAL WATCHDOG TIMEOUT). HOWEVER, INVESTIGATION IS STILL IN PROGRESS. A SUPPLEMENTAL REPORT WILL BE FILED WHEN INVESTIGATION HAS BEEN COMPLETED.

    Description of Event or Problem · 1

    COMPLAINANT ALLEGED THAT DURING A DEVICE CHECK, THE AUTOPULSE® PLATFORM DISPLAYED A "SYSTEM ERROR" MESSAGE AND WOULD NOT OPERATE. THERE WAS NO REPORT OF ANY PATIENT INVOLVEMENT. NO FURTHER DETAILS WERE PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    701446 AUTOPULSE® RESUSCITATION MODEL 100 CARDIAC CHEST COMPRESSOR DRM ZOLL CIRCULATION MODEL 100

    Patients

    Seq Age Sex Outcome Treatment
    1