BEUDAMED
    FDA Adverse Event Other Summary report: N

    LIFEPAK(R) 20 DEFIBRILLATOR/MONITOR

    MDR report key: 1805968 · Received August 11, 2010

    Report

    Report Number
    3015876-2010-00913
    Event Type
    Other
    Date Received
    August 11, 2010
    Date of Event
    July 9, 2010
    Report Date
    July 12, 2010
    Manufacturer
    PHYSIO-CONTROL, INC.
    Product Code
    LDD
    PMA / PMN Number
    K012274
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    BIOMEDICAL ENGINEER
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). PHYSIO- CONTROL EVALUATED THE DEVICE AND VERIFIED THE REPORTED FAILURE. PHYSIO IS IN THE PROCESS OF EVALUATING THE DEVICE AND WILL SUBMIT A SUPPLEMENTAL REPORT ON THIS EVENT TO THE FDA AS PROVIDED BY 21 CFR 803.56.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE DEVICE WAS INOPERATIVE WHILE ATTEMPTING TO MONITOR A PATIENT THAT WAS IN ACUTE REHABILITATION FACILITY. THE PATIENT HAD A RAPID HEART RATE OF 140 BPM AND THE DEVICE WAS RETRIEVED FOR MONITORING PURPOSES. THE PATIENT WAS CONSCIOUS, BREATHING AND HAD A PULSE WHEN THE USERS CONNECTED THE DEVICE TO PROVIDE CARE. AFTER POWERING ON, THE DEVICE WAS REPORTED TO LOSE POWER WHEN USERS TRIED TO MONITOR THE PATIENT. IT IS NOT CLEAR IF THE REPORTED FAILURE OCCURRED WITH EITHER AC OR DC POWER OR BOTH. THE PATIENT WAS IMMEDIATELY ADMITTED TO THE INTENSIVE CARE UNIT (ICU) WHERE HE WAS CONNECTED TO OTHER DEVICES TO MONITOR HIS CONDITION. THEREAFTER, THE PATIENT WAS TRANSFERRED TO ANOTHER FACILITY. DEFIBRILLATION THERAPY WAS NOT NEEDED ANYTIME DURING THE EVENT. THE DEVICE USE HAD NO ADVERSE EFFECT ON THE PATIENT. THE FACILITY BIOMED EVALUATED THE DEVICE AND FOUND IT POWERING ON PROPERLY BUT IT HAD ILLUMINATED THE SERVICE INDICATION DUE TO SEVERAL EVENT CODES THAT WERE LOGGED IN THE MEMORY.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR