BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIFEPAK 1000 DEFIBRILLATOR

    MDR report key: 1883871 · Received October 22, 2010

    Report

    Report Number
    3015876-2010-01171
    Event Type
    Malfunction
    Date Received
    October 22, 2010
    Date of Event
    September 23, 2010
    Report Date
    September 23, 2010
    Manufacturer
    PHYSIO-CONTROL, INC.
    Product Code
    MKJ
    PMA / PMN Number
    K042404
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PHYSIO-CONTROL EVALUATED THE DEVICE; HOWEVER, THE REPORTED FAILURE WAS NOT VERIFIED. PROPER DEVICE OPERATION WAS OBSERVED THROUGH FUNCTIONAL AND PERFORMANCE TESTING AND THE DEVICE WAS RETURNED TO THE CUSTOMER FOR USE. THE DEFIBRILLATION PADS WERE NOT AVAILABLE FOR EVALUATION. THE CAUSE OF THE REPORTED FAILURE COULD NOT BE DETERMINED.

    Description of Event or Problem · 1

    IT WAS REPORTED BY THE (B)(4) THAT THE DEVICE HAD PROMPTED "CONNECT ELECTRODES" DURING PT USE. IT WAS INDICATED THAT (B)(6) WAS INITIALLY WITH THIS PT. THE PT WAS IN CARDIAC ARREST. WHEN (B)(6) TRANSFERRED CARE OF THE PT TO (B)(6) , THE DEFIBRILLATION PADS (PHILIPS) WERE LEFT ON THE PT. THIS IS WHEN THE "CONNECT ELECTRODES" FAILURE WAS OBSERVED. IMMEDIATELY, THE PT WAS TRANSFERRED BACK TO THE DEVICE OF (B)(6) AND PT CARE WAS CONTINUED. THERE WAS NO ADVERSE EVENT AS A RESULT OF THE REPORTED FAILURE. NO PT SPECIFICS WERE PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LIFEPAK 1000 DEFIBRILLATOR MKJ PHYSIO-CONTROL, INC. 1000 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK