BEUDAMED
    FDA Adverse Event Summary report: N

    LIFELINE AED

    MDR report key: 1629006 · Received March 10, 2010

    Report

    Report Number
    3003521780-2010-00004
    Date Received
    March 10, 2010
    Date of Event
    February 4, 2010
    Report Date
    February 9, 2010
    Manufacturer
    DEFIBTECH, LLC
    Product Code
    MKJ
    Report Source
    Manufacturer report
    Reporter Location
    NL
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS RECEIVED BY THE MANUFACTURER ON MARCH 8TH, AND THE ROOT CAUSE INVESTIGATION REMAINS OPEN. NO CONCLUSION CAN BE MADE AT THIS TIME. A FOLLOW-UP REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING MAINTENANCE TESTING WITH A STIMULATOR, THE DEVICE FAILED TO DELIVER A SHOCK. 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-NL NA

    Patients

    Seq Age Sex Outcome Treatment
    1