BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIFEPAK(R) 20 DEFIBRILLATOR/MONITOR

    MDR report key: 2941871 · Received February 4, 2013

    Report

    Report Number
    3015876-2013-00083
    Event Type
    Malfunction
    Date Received
    February 4, 2013
    Date of Event
    January 8, 2013
    Report Date
    January 8, 2013
    Manufacturer
    PHYSIO-CONTROL, INC
    Product Code
    LDD
    PMA / PMN Number
    K063119
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). PHYSIO-CONTROL PROVIDED THE CUSTOMER WITH THE NECESSARY INFORMATION TO REPAIR THE DEVICE. UPON SUCCESSFUL COMPLETION OF THE REPAIR AND AFTER OBSERVING PROPER DEVICE OPERATION THROUGH FUNCTIONAL AND PERFORMANCE TESTING; THE DEVICE WILL BE RETURNED TO USE.

    Additional Manufacturer Narrative · 1

    PHYSIO-CONTROL FURTHER EVALUATED THE REMOVED SYSTEM CONTROLLER AND USER INTERFACE PCB ASSEMBLIES AT THE FAILURE ANALYSIS CENTER AND DETERMINED THE CAUSE OF THE FAILURE TO BE DUE TO INTEGRATED CIRCUIT CHIP, DESIGNATOR U61, ON THE SYSTEM CONTROLLER PCB ASSEMBLY. NO FAILURE OF THE USER INTERFACE PCB ASSEMBLY WAS NOTED AND IT WAS CONFIRMED TO BE AN ANCILLARY REPLACED PART.

    Additional Manufacturer Narrative · 1

    PHYSIO-CONTROL CONFIRMED WITH THE CUSTOMER THAT THE FAILURE WAS RESOLVED BY REPLACING THE USER INTERFACE FLEX CABLE ASSEMBLY. THE CUSTOMER LATER CONTACTED PHYSIO-CONTROL TO INDICATE THE FAILURE HAD NOT ACTUALLY BEEN RESOLVED. PHYSIO-CONTROL EVALUATED THE DEVICE AND VERIFIED THE REPORTED FAILURE. PHYSIO REPLACED THE SYSTEM CONTROLLER AND USER INTERFACE PCB ASSEMBLIES AND OBSERVED PROPER DEVICE OPERATION THROUGH FUNCTIONAL AND PERFORMANCE TESTING. THE DEVICE WAS THEN RETURNED TO THE CUSTOMER FOR USE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE DEVICE LOCKED-UP DURING POWER UP AND WOULD NOT ADVANCE PAST THE SELF TEST SCREEN. THERE WAS NO PATIENT USE ASSOCIATED WITH THE REPORTED FAILURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    46351 LIFEPAK(R) 20 DEFIBRILLATOR/MONITOR DC-DEFIBRILLATOR, LOW-ENERGY, (INCLUDING PADDLES) LDD PHYSIO-CONTROL, INC 20

    Patients

    Seq Age Sex Outcome Treatment
    1