BEUDAMED
    FDA Adverse Event Death Summary report: N

    LIFELINE VIEW AED

    MDR report key: 1970056 · Received January 20, 2011

    Report

    Report Number
    3003521780-2011-00001
    Event Type
    Death
    Date Received
    January 20, 2011
    Date of Event
    December 7, 2010
    Report Date
    December 13, 2010
    Manufacturer
    DEFIBTECH, LLC
    Product Code
    MKJ
    PMA / PMN Number
    K081259
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    DE, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    REPORT IS BEING SUBMITTED BY THE MFR AFTER ROUTINE REVIEW OF A FIELD EVENT. THE REVIEW OF A DEVICE'S INTERNAL HISTORY RECORD IDENTIFIED THAT DURING A RESCUE ATTEMPT ON (B)(6) 2010, THE PT WAS IN VENTRICULAR FIBRILLATION, HOWEVER, THE DEVICE DID NOT DELIVER A SHOCK DUE TO POOR PT CONNECTION. TYPICALLY, A SHOCK IS INDICATED IN THIS SITUATION, UNLESS THERE IS INTERFERENCE OR POOR PAD CONTACT. THE END CUSTOMER REPORTS THAT WHILE ASSESSING THE PT THEY SHOOK THE PT AND TOUCHED THE DEFIBRILLATION ELECTRODES WHILE THE DEVICE WAS OPERATING. TO RULE OUT ANY POSSIBLY OF DEVICE MALFUNCTION, THE RETURN OF THE AED HAS BEEN REQUESTED TO ASSIST FURTHER WITH THE INVESTIGATION. NO CONCLUSION CAN BE MADE AT THIS TIME AND THE INVESTIGATION REMAINS OPEN.

    Description of Event or Problem · 1

    REPORT IS BEING SUBMITTED BY THE MFR AFTER ROUTINE REVIEW OF A FIELD EVENT. THE REVIEW OF A DEVICE'S INTERNAL HISTORY RECORD IDENTIFIED THAT DURING A RESCUE ATTEMPT ON (B)(6) 2010, THE PT WAS IN VENTRICULAR FIBRILLATION, HOWEVER, THE DEVICE DID NOT DELIVER A SHOCK DUE TO POOR PT CONNECTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LIFELINE VIEW AED SEMI-AUTOMATIC EXTERNAL DEFIBRILLATOR MKJ DEFIBTECH, LLC DDU-C2300 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 59 YR Death