BEUDAMED
    FDA Adverse Event Summary report: N

    LIFELINE AED

    MDR report key: 2594068 · Received May 24, 2012

    Report

    Report Number
    3003521780-2012-00003
    Date Received
    May 24, 2012
    Date of Event
    April 26, 2012
    Report Date
    April 26, 2012
    Manufacturer
    DEFIBTECH, LLC
    Product Code
    MKJ
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE HAS NOT BEEN REQUESTED TO BE RETURNED TO THE MFR TO ASSIST WITH THE INVESTIGATION, HOWEVER, TO DATE, IT HAS NOT BEEN RETURNED. UPON FOLLOW-UP BY THE MFR, THE END CUSTOMER REPORTED THAT THEY BELIEVE THAT THEY MAY HAVE THROWN THE EQUIPMENT AWAY. NO CONCLUSIONS CAN BE MADE.

    Description of Event or Problem · 1

    ON 04/26/2012, IT WAS REPORTED THAT AN AED WAS CONNECTED TO A PT SIMULATOR AND THAT WHEN THE SHOCK BUTTON WAS PASSED THE DEVICE DID NOT DELIVER THERAPY. 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-100 NA

    Patients

    Seq Age Sex Outcome Treatment
    1