BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIFEPAK(R) 20 DEFIBRILLATOR/MONITOR

    MDR report key: 3173631 · Received June 17, 2013

    Report

    Report Number
    3015876-2013-00516
    Event Type
    Malfunction
    Date Received
    June 17, 2013
    Date of Event
    May 20, 2013
    Report Date
    May 20, 2013
    Manufacturer
    PHYSIO-CONTROL, INC
    Product Code
    LDD
    PMA / PMN Number
    K063119
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4): PHYSIO-CONTROL REPLACED THE USER INTERFACE PCB, SYSTEM CONTROLLER PCB AND THE KEYPAD ASSEMBLIES TO RESOLVE THE INTERMITTENT FAILURE. PHYSIO REPAIRED THE DEVICE AND OBSERVED PROPER DEVICE OPERATION THROUGH FUNCTIONAL AND PERFORMANCE TESTING. THE DEVICE WAS RETURNED TO THE CUSTOMER FOR USE.

    Additional Manufacturer Narrative · 1

    PHYSIO-CONTROL¿S FURTHER EVALUATION OF THE REMOVED USER INTERFACE PCB ASSEMBLY DETERMINED THE CAUSE FOR THE PROBLEM TO BE THE ON/OFF BUTTON METALLIC DOME SURFACE THAT WAS WORN AND REQUIRED MORE PRESSURE THAN NORMAL TO ENGAGE. AS SUCH, THE ON/OFF BUTTON RESPONDED INTERMITTENTLY WITH NORMAL PRESSURE. THERE WAS NO FAILURE WITH THE REMOVED SYSTEM CONTROLLER PCB ASSEMBLY AND NO FURTHER ANALYSIS COMPLETED FOR THE REMOVED KEYPAD DUE TO DAMAGE THAT OCCURRED DURING REPAIR.

    Description of Event or Problem · 1

    THE CUSTOMER SENT THE DEVICE TO PHYSIO-CONTROL FOR REPAIR AFTER IT WAS DROPPED AND THE ECG CONNECTOR BROKE. PHYSIO-CONTROL EVALUATED THE DEVICE AND OBSERVED INTERMITTENT OPERATION OF THE DEVICE POWER ON/OFF BUTTON. THERE WAS NO PATIENT USE ASSOCIATED WITH THE EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    274306 LIFEPAK(R) 20 DEFIBRILLATOR/MONITOR DC-DEFIBRILLATOR, LOW-ENERGY, (INCLUDING PADDLES) LDD PHYSIO-CONTROL, INC 20

    Patients

    Seq Age Sex Outcome Treatment
    1