BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIFEPAK 20 DEFIBRILLATOR/MONITOR

    MDR report key: 1232115 · Received November 4, 2008

    Report

    Report Number
    3015876-2008-01577
    Event Type
    Malfunction
    Date Received
    November 4, 2008
    Date of Event
    October 5, 2008
    Report Date
    October 6, 2008
    Manufacturer
    PHYSIO-CONTROL, INC.
    Product Code
    LDD
    PMA / PMN Number
    K012274
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    RI, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE HOSPITAL BIOMEDICAL DEPARTMENT REMOVED THE DEVICE FROM USE AND CONNECTED IT TO AC POWER TO RECHARGE THE BATTERY. AFTER THE BATTERY WAS RE-CHARGED, THE BIOMED EVALUATED, THE DEVICE AND COULD NOT REPLICATE THE DEVICE SHUT-DOWN ON BATTERY POWER. PHYSIO-CONTROL EVALUATED THE DEVICE AND OBSERVED PROPER OPERATION THROUGH FUNCTIONAL AND PERFORMANCE TESTING. THE DEVICE WAS RETURNED TO THE CUSTOMER FOR USE. ROOT CAUSE COULD NOT BE CONCLUSIVELY DETERMINED, BUT MAY HAVE BEEN DUE TO A NORMALLY CHARGE DEPLETED BATTERY.

    Description of Event or Problem · 1

    A PATIENT WAS BEING MONITORED AND PACED WITH THE DEVICE WHILE BEING TRANSPORTED TO AN OPERATING ROOM WHEN, ACCORDING TO THE REPORTER, THE DEVICE POWERED ITSELF OFF. THE NURSES TRANSPORTING THE PATIENT WERE IN THE MIDDLE OF THE CORRIDOR AND DID NOT STOP TO TROUBLESHOOT. THEY CONTINUED ON TO THE OPERATING ROOM WHERE THE PATIENT WAS PUT ON ANOTHER MONITOR THERE. THE REPORTER INDICATED THAT THE TIME THAT THE PATIENT WAS WITHOUT A DEVICE WAS APPROXIMATELY 10 MINUTES. THE PATIENT RECEIVED A PACEMAKER AND NO ADVERSE AFFECTS TO THE PATIENT WERE REPORTED TO OCCUR AS A RESULT OF THE DEVICE USE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LIFEPAK 20 DEFIBRILLATOR/MONITOR LDD PHYSIO-CONTROL, INC. 20 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK