BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIFEPAK(R) 20E DEFIBRILLATOR/MONITOR

    MDR report key: 3022724 · Received March 27, 2013

    Report

    Report Number
    3015876-2013-00236
    Event Type
    Malfunction
    Date Received
    March 27, 2013
    Date of Event
    February 22, 2013
    Report Date
    February 26, 2013
    Manufacturer
    PHYSIO-CONTROL, INC
    Product Code
    MKJ
    PMA / PMN Number
    K073089
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4): THE DEVICE WAS NOT EVALUATED BY PHYSIO-CONTROL. A THIRD PARTY AGENT EVALUATED THE DEVICE AND VERIFIED THE REPORTED FAILURE. THEN THE THIRD PARTY AGENT REPLACED THE SYSTEM AND USER INTERFACE PCB, UPDATED THE DEVICE TO THE LATEST SOFWARE VERSION AND CALIBRATED IT. AFTER OBSERVING PROPER DEVICE OPERATION THOUGH FUNCTIONAL AND PERFORMANCE TESTING, THE DEVICE WAS RETURNED TO THE CUSTOMER FOR USE.

    Additional Manufacturer Narrative · 1

    THE THIRD PARTY SERVICE AGENT SENT THE REMOVED SYSTEM CONTROLLER AND USER INTERFACE PCB ASSEMBLIES TO THE FAILURE ANALYSIS CENTER AT PHYSIO-CONTROL FOR FURTHER EVALUATION. THE REPORTED POWER FAILURE AND EVENT CODES COULD NOT BE REPRODUCED DURING TESTING. THE CAUSE OF THE REPORTED FAILURE COULD NOT BE DETERMINED.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT THEIR DEVICE POWERED ITSELF OFF. THE CUSTOMER ALSO REPORTED THAT THE DEVICE HAD MULTIPLE EVENT CODES LOGGED IN THE SERVICE HISTORY. THERE WAS NO PATIENT USE ASSOCIATED WITH THE REPORTED FAILURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    127077 LIFEPAK(R) 20E DEFIBRILLATOR/MONITOR DEFIBRILLATORS, AUTOMATIC, EXTERNAL MKJ PHYSIO-CONTROL, INC 20E

    Patients

    Seq Age Sex Outcome Treatment
    1