BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AUTOPULSE RESUSCITATION SYSTEM MODEL 100

    MDR report key: 2935821 · Received January 2, 2013

    Report

    Report Number
    3003793491-2012-00686
    Event Type
    Malfunction
    Date Received
    January 2, 2013
    Date of Event
    October 2, 2012
    Report Date
    October 3, 2012
    Manufacturer
    ZOLL CIRCULATION INC.
    Product Code
    DRM
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE AUTOPULSE DEVICE (SN (B)(4)) INVOLVED IN THE EVENT WAS RETURNED TO ZOLL CIRCULATION ON (B)(4) 2012 AND WAS ANALYZED. VISUAL INSPECTION OF THE AUTOPULSE SHOWED NO DAMAGES. REPORTED PROBLEM WAS CONFIRMED. THE ARCHIVE DATA SHOW MULTIPLE UA41 (PATIENT TEMPERATURE SENSOR FAILURE). IT WAS OBSERVED THAT THE TEMPERATURE SENSOR CONNECTOR WAS NOT CONNECTED INTO THE POWER DISTRIBUTION BOARD. THE TEMPERATURE SENSOR CONNECTOR WAS RECONNECTED INTO THE POWER DISTRIBUTION BOARD. AFTER RECONNECTED, THE TEMPERATURE SENSOR INTO POWER DISTRIBUTION BOARD, THE DEVICE PASSED FINAL TEST. NO ADVERSE EVENT WAS REPORTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT UNIT DISPLAYS "USER ADVISORY 41 (PATIENT TEMPERATURE SENSOR FAILURE)" ON POWER UP DURING THE MORNING CHECKS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1533 AUTOPULSE RESUSCITATION SYSTEM MODEL 100 CARDIAC CHEST COMPRESSOR DRM ZOLL CIRCULATION INC. MODEL 100

    Patients

    Seq Age Sex Outcome Treatment
    1 Other