BEUDAMED
    FDA Adverse Event Summary report: N

    LIFELINE AED

    MDR report key: 1661795 · Received April 19, 2010

    Report

    Report Number
    3003521780-2010-00007
    Date Received
    April 19, 2010
    Date of Event
    March 19, 2010
    Report Date
    March 19, 2010
    Manufacturer
    DEFIBTECH, LLC
    Product Code
    MKJ
    Report Source
    Manufacturer report
    Reporter Location
    NL
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THE ELECTRONIC HISTORY RECORD FROM THE ACTUAL DEVICE INVOLVED IN THE INCIDENT WAS EVALUATED. RESULT: THE RECORD INDICATES THAT, WHILE CONNECTED TO A PT SIMULATOR DURING ROUTINE MAINTENANCE, THE DEVICE BEGAN TO CHARGE AND THEN CANCELLED A SHOCK. NO CONCLUSION CAN BE MADE AT THIS TIME AND COORDINATION EFFORTS HAVE BEEN IMPLEMENTED FOR RETURN OF THE EQUIPMENT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING ROUTINE MAINTENANCE TESTING WITH A PT SIMULATOR, THE DEVICE FAILED TO DELIVER A SHOCK. THERE WAS NO PT INVOLVEMENT.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1