BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BIPHASIC LIFEPAK 500 AUTOMATED EXTERNAL DEFIBRILLATOR

    MDR report key: 1843623 · Received September 22, 2010

    Report

    Report Number
    3015876-2010-01046
    Event Type
    Malfunction
    Date Received
    September 22, 2010
    Date of Event
    August 27, 2010
    Report Date
    August 27, 2010
    Manufacturer
    PHYSIO-CONTROL, INC.
    Product Code
    MKJ
    PMA / PMN Number
    K983393
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4): PHYSIO-CONTROL EVALUATED THE DEVICE, HOWEVER, THE REPORTED FAILURE WAS NOT VERIFIED NOR DUPLICATED. PROPER OPERATION WAS OBSERVED THROUGH FUNCTIONAL AND PERFORMANCE TESTING, AND THE DEVICE WAS RETURNED TO THE CUSTOMER FOR USE. THE CAUSE OF THE REPORTED FAILURE COULD NOT BE DETERMINED.

    Description of Event or Problem · 1

    IT WAS REPORTED BY THE CUSTOMER THAT THEY RESPONDED TO A PT CALL WHO HAD STOPPED BREATHING. THE LOCAL FIRE DEPT WAS ALSO DISPATCHED TO THE SCENE. ARRIVAL TIME OF THE TWO CREWS WAS WITHIN THREE MINUTES. THE PT WAS ALREADY IN CARDIAC ARREST UPON THEIR ARRIVAL. CPR WAS INITIATED, AND THE DEVICE WAS CONNECTED TO THE PT. THE DEVICE CONTINUED TO PROMPT "CONNECT ELECTRODES" WITH A SET OF KENDALL DEFIBRILLATOR PADS (UNK EXP DATE) ATTACHED. A NEW SET OF KENDALL DEFIBRILLATOR PADS (UNK EXP DATE) WERE CONNECTED, WITH THE SAME FAILURE OBSERVED. AT THAT TIME, THE FIRE DEPT'S DEVICE WAS PLACED ON THE PT. IT IS UNK WHAT TYPE OF DEVICE AND PADS THEY HAD, BUT IT IS KNOWN THAT THEY WERE NOT PHYSIO-CONTROL BRAND. AT THAT TIME, THE PT HAD A NON-SHOCKABLE RHYTHM. CPR WAS CONTINUED AND THE PT CONVERTED INTO A SHOCKABLE RHYTHM. DEFIBRILLATION WAS DELIVERED AND CPR CONTINUED UNTIL A PULSE WAS REGAINED. THE PT WAS DELIVERED TO THE HOSP, WHERE IT WS CONFIRMED THAT SHE HAD SUFFERED A DRUG OVERDOSE. THE PT IS IN A STABLE STATE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BIPHASIC LIFEPAK 500 AUTOMATED EXTERNAL DEFIBRILLATOR MKJ PHYSIO-CONTROL, INC. NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 37 YR