BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    POWERHEART AED G3

    MDR report key: 4080883 · Received August 27, 2014

    Report

    Report Number
    3009249335-2014-00013
    Event Type
    Malfunction
    Date Received
    August 27, 2014
    Date of Event
    July 28, 2014
    Report Date
    July 31, 2014
    Manufacturer
    CARDIAC SCIENCE CORPORATION
    Product Code
    MKJ
    PMA / PMN Number
    K031987
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THE AED WAS RETURNED TO CARDIAC SCIENCE AND IS BEING EVALUATED.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THE FOLLOWING: UNIT WAS SHOWING 'RESCUE READY' MEANING ALL INTERNAL CHECKS HAVE BEEN CARRIED OUT AND UNIT IS WORKING FINE. ON OPENING THE LID, THE UNIT DID NOT SWITCH ON AND COULD NOT HAVE BEEN USED IN AN INCIDENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    518959 POWERHEART AED G3 AUTOMATED EXTERNAL DEFIBRILLATOR MKJ CARDIAC SCIENCE CORPORATION 9300E NA

    Patients

    Seq Age Sex Outcome Treatment
    1