BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIFELINE, AED

    MDR report key: 1302890 · Received December 31, 2008

    Report

    Report Number
    3003521780-2008-00030
    Event Type
    Malfunction
    Date Received
    December 31, 2008
    Date of Event
    October 2, 2007
    Report Date
    October 12, 2007
    Manufacturer
    DEFIBTECH, LLC
    Product Code
    MKJ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    SUMMARY: REVIEW OF THE DEVICE'S ELECTRONIC HISTORY FILE INDICATED THAT THE DEVICE WAS ATTACHED TO A SIMULATOR AND THAT IT INDICATED THAT A SHOCK WAS REQUIRED. IT THEN CANCELLED THE SHOCK AND REPORTED A SERVICE MESSAGE. TESTING PERFORMED HAS BEEN UNABLE TO REPRODUCE ERROR MODE REPORTED. THE INVESTIGATION REMAINS OPEN. RESULTS: THE ACTUAL DEVICE HAS BEEN EVALUATED. TESTING PERFORMED HAS BEEN UNABLE TO REPRODUCE ERROR MODE REPORTED. NO CONCLUSIONS CAN BE MADE AT THIS TIME. THE INVESTIGATION REMAINS OPEN.

    Description of Event or Problem · 1

    A DEVICE REPORTED A SERVICE MESSAGE DURING MAINTENANCE. THERE WAS NO PATIENT INVOLVEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LIFELINE, AED SEMI-AUTOMATIC EXTERNAL DEFIBRILLATOR MKJ DEFIBTECH, LLC DDU-100E-IT NA

    Patients

    Seq Age Sex Outcome Treatment
    1