BEUDAMED
    FDA Adverse Event Other Summary report: N

    AUTOPULSE RESUSCITATION SYSTEM MODEL 100

    MDR report key: 3057518 · Received March 21, 2013

    Report

    Report Number
    3003793491-2013-00406
    Event Type
    Other
    Date Received
    March 21, 2013
    Date of Event
    February 28, 2013
    Report Date
    February 28, 2013
    Manufacturer
    ZOLL CIRCULATION, INC.
    Product Code
    DRM
    PMA / PMN Number
    K112998
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    NOT APPLICABLE
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 1

    ZOLL MEDICAL CORPORATION HAS NOT YET RECEIVED THE DEVICE. A SUPPLEMENTAL REPORT WILL BE SUBMITTED IF THE DEVICE IS RECEIVED AND WHEN IT IS EVALUATED. AUTOPLUS S/N (B)(4) MFR REPORT # 3003793491-2013-00337. BATTERY S/N (B)(4) MFR REPORT # 3003793491-2013-00338. BATTERY S/N (B)(4) MFR REPORT # 3003793491-2013-00339.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE DEVICE STOPPED SUDDENLY DISPLAYING THE BATTERY EMPTY ICON ON THE LCD. THE BATTERY WAS FULLY CHARGED. ACHIEVE FILE WAS REVIEWED, THE PLATFORM INDICATED USER ADVISORY 8 (MOTOR CONTROLLER FAULT DETECTED) AND USER ADVISORY 17 (MAX MOTOR ON TIME EXCEEDED DURING ACTIVE OPERATION). NO OTHER INFO WAS PROVIDED. THERE WAS NO ADVERSE PT SEQUELA REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    118456 AUTOPULSE RESUSCITATION SYSTEM MODEL 100 CARDIAC CHEST COMPRESSOR DRM ZOLL CIRCULATION, INC. 100 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Other