BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AUTOPULSE RESUSCITATION SYSTEM MODEL 100

    MDR report key: 2943517 · Received January 9, 2013

    Report

    Report Number
    3003793491-2012-00597
    Event Type
    Malfunction
    Date Received
    January 9, 2013
    Date of Event
    December 11, 2012
    Report Date
    December 11, 2012
    Manufacturer
    ZOLL CIRCULATION, INC
    Product Code
    DRM
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS ANALYZED. THE INITIAL COMPLAINT OF THE AUTOPULSE RESUSCITATION SYSTEM UNIT HAVING DAMAGED MOTOR AND ENCODER COVERS WAS VERIFIED. A FAULTY LOAD CELL J6 WAS ALSO CONFIRMED AND ARCHIVE INDICATED THAT DAMAGED LOAD CELL WAS CAUSING USER ADVISORY UA02 (COMPRESSION TRACKING ERROR) MESSAGES. THE MOTOR AND ENCODER COVERS WERE REPLACED. DAMAGED LOAD CELL J6 WAS ALSO REPLACED. THE LOANER PASSED FINAL TEST.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT AUTOPULSE RESUSCITATION SYSTEM SERVICE LOANER HAS A DAMAGED MOTOR AND ENCODER COVER. ALSO LOAD CELL 1 NEEDS TO BE REPLACED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    11284 AUTOPULSE RESUSCITATION SYSTEM MODEL 100 CARDIAC CHEST COMPRESSOR DRM ZOLL CIRCULATION, INC 100

    Patients

    Seq Age Sex Outcome Treatment
    1 Other