BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIFEPAK(R) 20 DEFIBRILLATOR/MONITOR

    MDR report key: 3801014 · Received May 8, 2014

    Report

    Report Number
    3015876-2014-00515
    Event Type
    Malfunction
    Date Received
    May 8, 2014
    Date of Event
    April 9, 2014
    Report Date
    April 9, 2014
    Manufacturer
    PHYSIO-CONTROL, INC
    Product Code
    LDD
    PMA / PMN Number
    K063119
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). PHYSIO-CONTROL EXAMINED THE CUSTOMER'S DEVICE AND OBSERVED THAT, WHEN RECEIVED, THE UNIT'S INTERNAL BATTERY WAS COMPLETELY DEPLETED AND REQUIRED CHARGING. PHYSIO PLUGGED IN THE DEVICE TO CHARGE AND THEN ONCE COMPLETE, CONTINUED TESTING THE DEVICE. PHYSIO WAS UNABLE TO DUPLICATE THE POWER OFF ISSUE AND FOUND THAT THE DEVICE POWERED ON, CHARGED AND PROVIDED DEFIBRILLATION SHOCKS WHEN PROMPTED. AFTER OBSERVING PROPER DEVICE OPERATION THROUGH FUNCTIONAL AND PERFORMANCE TESTING THE UNIT WAS RETURNED TO THE CUSTOMER FOR USE. THE CAUSE OF THE REPORTED ISSUE COULD NOT BE DETERMINED.

    Description of Event or Problem · 1

    THE CUSTOMER, A BIOMEDICAL ENGINEER, CONTACTED PHYSIO-CONTROL TO REPORT THAT WHEN TESTING THEIR DEVICE HE OBSERVED THAT IT POWERED OFF BY ITSELF WHEN ATTEMPTING TO CHARGE PAST 10 JOULES. THERE WAS NO PATIENT USE ASSOCIATED WITH THE REPORTED EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    277675 LIFEPAK(R) 20 DEFIBRILLATOR/MONITOR DC-DEFIBRILLATOR, LOW-ENERGY, (INCLUDING PADDLES) LDD PHYSIO-CONTROL, INC 20

    Patients

    Seq Age Sex Outcome Treatment
    1