BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AUTOPULSE® RESUSCITATION SYSTEM MODEL 100

    MDR report key: 3945539 · Received July 21, 2014

    Report

    Report Number
    3003793491-2014-00363
    Event Type
    Malfunction
    Date Received
    July 21, 2014
    Date of Event
    January 1, 2012
    Report Date
    April 24, 2014
    Manufacturer
    ZOLL CIRCULATION, INC
    Product Code
    DRM
    PMA / PMN Number
    K112998
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    PLEASE SEE THE FOLLOWING RELATED MFR REPORT: # 3003793491-2014-00362. PRODUCT IN COMPLAINT WILL NOT BE RETURNED. THEREFORE, PHYSICAL INVESTIGATION CANNOT BE PERFORMED. A SUPPLEMENTAL REPORT WILL BE FILED IF THE PRODUCT IN COMPLAINT IS RETURNED AND INVESTIGATION IS COMPLETED.

    Description of Event or Problem · 1

    THE FOLLOWING INFORMATION WAS RECEIVED THROUGH A REVIEW OF A TRANSLATED VIGILANCE REPORT. IT WAS REPORTED THAT THE AUTOPULSE WAS DISPLAYING A USER ADVISORY (UA) 21 MESSAGE (POSITION CHANGE DOES NOT COINCIDE WITH MOTOR DIRECTION). NO SPECIFIC DETAILS WERE PROVIDED. NO ADVERSE PATIENT SEQUELAE WAS REPORTED. PLEASE NOTE THAT THE EXACT DATE OF THIS EVENT IS UNKNOWN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    424375 AUTOPULSE® RESUSCITATION SYSTEM MODEL 100 CARDIAC CHEST COMPRESSOR DRM ZOLL CIRCULATION, INC MODEL 100

    Patients

    Seq Age Sex Outcome Treatment
    1