BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AUTOPULSE RESUSCITATION SYSTEM MODEL 100

    MDR report key: 2943518 · Received January 9, 2013

    Report

    Report Number
    3003793491-2012-00596
    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
    UT, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ZOLL MEDICAL CORPORATION HAS NOT RECEIVED THE PRODUCT FOR EVALUATION. IF THE PRODUCT IS RETURNED TO THE MANUFACTURER, A SUPPLEMENTAL REPORT WILL BE FILED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT AUTOPULSE RESUSCITATION SYSTEM DISPLAYED A USER ADVISORY MESSAGE OF UA12 (LIFEBAND NOT PRESENT). CUSTOMER INDICATED THAT A LIFEBAND WAS INSTALLED, HOWEVER USER ADVISORY MESSAGE WAS UNABLE TO BE CLEARED. CUSTOMER ALSO BELIEVES THAT A UA45 (NOT AT "HOME" POSITION AFTER POWER-ON/RESTART) ALSO DISPLAYED ON THE AUTOPULSE DEVICE PRIOR TO THIS INCIDENT. THERE WAS NO REPORT OF A PATIENT INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    13101 AUTOPULSE RESUSCITATION SYSTEM MODEL 100 CARDIAC CHEST COMPRESSOR DRM ZOLL CIRCULATION, INC. MODEL 100

    Patients

    Seq Age Sex Outcome Treatment
    1 Other