BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIFEPAK(R) 12 DEFIBRILLATOR/MONITOR SERIES

    MDR report key: 4202549 · Received October 27, 2014

    Report

    Report Number
    3015876-2014-01267
    Event Type
    Malfunction
    Date Received
    October 27, 2014
    Date of Event
    September 28, 2014
    Report Date
    September 28, 2014
    Manufacturer
    PHYSIO-CONTROL, INC
    Product Code
    MKJ
    PMA / PMN Number
    K102972
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PHYSIO-CONTROL EVALUATED THE DEVICE AND VERIFIED THE REPORTED INTERMITTENT DEVICE ISSUE. PHYSIO THEN REPLACED THE THERAPY CABLE ASSEMBLY AND OBSERVED PROPER DEVICE OPERATION THROUGH FUNCTIONAL AND PERFORMANCE TESTING AND THE DEVICE WAS THEN RETURNED TO THE CUSTOMER FOR USE. PHYSIO-CONTROL PERFORMED A CLINICAL REVIEW ON THE REPORTED EVENT AND DETERMINED THAT THE REPORTED DEVICE ISSUE DID NOT CONTRIBUTE TO THE DEATH OF THE PATIENT.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT DURING A PATIENT EVENT, THEIR DEVICE WAS NOT RECOGNIZING THE CONNECTION OF THE DEFIBRILLATION ELECTRODES TO THE PATIENT. THE CUSTOMER INDICATED THAT THE PATIENT WAS WITNESSED DOWN BY A RELATIVE THEN 911 WAS CALLED. WHEN THE EMTS ARRIVED ON SCENE, THE PATIENT WAS UNRESPONSIVE. THE CUSTOMER CONNECTED THE DEFIBRILLATION ELECTRODES TO THE PATIENT AND THE DEVICE BUT WAS UNABLE TO VIEW A ECG RHYTHM ON THE DEVICE. THE CUSTOMER THEN CONNECTED THE 3 LEAD ECG CABLE AND WAS ABLE TO OBTAIN THE PATIENT'S ECG RHYTHM. THE CUSTOMER INDICATED THAT A BACK UP DEVICE ARRIVED ON SCENE APPROXIMATELY (5) FIVE MINUTES LATER. THE PATIENT'S RELATIVES DID INDICATE THAT THE PATIENT HAD A DNR (DO NOT RESUSCITATE) ORDER. THE PATIENT DID NOT RECEIVE ANY DEFIBRILLATION SHOCKS DURING THE EVENT. AFTER AN EVALUATION OF THE ELECTRONIC PATIENT RECORD, IT WAS OBSERVED THAT THE DEVICE WAS NOT PLACED INTO PADDLES LEAD, WHICH IS REQUIRED IN ORDER TO VIEW THE PATIENT'S ECG FROM THE DEFIBRILLATION THERAPY ELECTRODES. IT WAS HOWEVER INDICATED THROUGH SUBSEQUENT DEVICE TESTING, THAT THE THERAPY CABLE ASSEMBLY CONNECTED TO THE PATIENT WAS SHOWING AN INTERMITTENT LEADS OFF CONDITION. THE PATIENT DID NOT SURVIVE THE EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    683909 LIFEPAK(R) 12 DEFIBRILLATOR/MONITOR SERIES DEFIBRILLATORS, AUTOMATIC, EXTERNAL MKJ PHYSIO-CONTROL, INC

    Patients

    Seq Age Sex Outcome Treatment
    1