BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIFEPAK(R) 20 DEFIBRILLATOR/MONITOR

    MDR report key: 3812488 · Received May 15, 2014

    Report

    Report Number
    3015876-2014-00545
    Event Type
    Malfunction
    Date Received
    May 15, 2014
    Date of Event
    March 11, 2014
    Report Date
    April 23, 2014
    Manufacturer
    PHYSIO-CONTROL, INC
    Product Code
    LDD
    PMA / PMN Number
    K063119
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). PHYSIO-CONTROL EVALUATED THE CUSTOMER¿S DEVICE AND VERIFIED THE REPORTED FAILURE. PHYSIO-CONTROL REPLACED THE SYSTEM CONTROLLER AND USER INTERFACE PCB ASSEMBLIES. THEREAFTER PROPER DEVICE OPERATION WAS OBSERVED THROUGH FUNCTIONAL AND PERFORMANCE TESTING AND THE DEVICE WAS RETURNED TO THE CUSTOMER FOR USE. PHYSIO-CONTROL FURTHER EVALUATED THE REMOVED SYSTEM CONTROLLER AND USER INTERFACE PCB ASSEMBLIES. IT WAS DETERMINED THAT THE CAUSE OF THE REPORTED FAILURE WAS THE USER INTERFACE PCB ASSEMBLY. COMPONENT LEVEL CAUSE COULD NOT BE DETERMINED.

    Description of Event or Problem · 1

    THE CUSTOMER CONTACTED PHYSIO-CONTROL TO REPORT THAT THE DISPLAY IN THEIR DEVICE WAS DISTORTED. THE CUSTOMER REPLACED THE DISPLAY BUT THAT DID NOT RESOLVE THE ISSUE. THERE WAS NO PATIENT USE ASSOCIATED WITH THE REPORTED EVENT. UPON EVALUATION OF THE DEVICE, PHYSIO-CONTROL OBSERVED THE DEVICE RESET CONTINUOUSLY. THIS OCCURRED ONLY ONCE DURING TESTING. IN THIS STATE, THE DEVICE WOULD BE INOPERABLE AND DEFIBRILLATION THERAPY WOULD NOT BE AVAILABLE IF NEEDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    292018 LIFEPAK(R) 20 DEFIBRILLATOR/MONITOR DC-DEFIBRILLATOR, LOW-ENERGY, (INCLUDING PADDLES) LDD PHYSIO-CONTROL, INC 20

    Patients

    Seq Age Sex Outcome Treatment
    1