BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIFEPAK(R) 20 DEFIBRILLATOR/MONITOR

    MDR report key: 3200248 · Received July 1, 2013

    Report

    Report Number
    3015876-2013-00563
    Event Type
    Malfunction
    Date Received
    July 1, 2013
    Date of Event
    May 24, 2013
    Report Date
    June 5, 2013
    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 EXAMINED THE CUSTOMER'S DEVICE AND VERIFIED THE REPORTED FAILURE. PHYSIO REPLACED BOTH THE SYSTEM CONTROLLER (SC) AND USER INTERFACE (UI) PCB ASSEMBLIES AS WELL AS THE UI TO STACK FLEX ASSEMBLY WHICH RESOLVED THE REPORTED FAILURE. AFTER OBSERVING PROPER DEVICE OPERATION THROUGH FUNCTIONAL AND PERFORMANCE TESTING THE UNIT WAS RETURNED TO THE CUSTOMER FOR USE.PHYSIO-CONTROL FURTHER EXAMINED THE REMOVED SC AND UI PCB ASSEMBLIES, AS WELL AS THE UI TO STACK FLEX ASSEMBLY, BUT WAS UNABLE TO DUPLICATE THE REPORTED LOCK-UP FAILURE. THE CAUSE OF THE REPORTED FAILURE COULD NOT BE DETERMINED.

    Description of Event or Problem · 1

    THE CUSTOMER CONTACTED PHYSIO-CONTROL TO REPORT THAT THEIR DEVICE HAD A SERVICE INDICATOR PRESENT AND WOULD NO LONGER KEEP THE CORRECT DATE AND TIME. UPON EXAMINATION OF THE DEVICE, PHYSIO-CONTROL OBSERVED THAT THE UNIT HAD A WHITE DISPLAY WHICH IS INDICATIVE OF A DEVICE LOCK-UP; THEREFORE DEFIBRILLATION WOULD NOT BE POSSIBLE. THERE WAS NO PATIENT USE ASSOCIATED WITH THE REPORTED EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    299295 LIFEPAK(R) 20 DEFIBRILLATOR/MONITOR DC-DEFIBRILLATOR, LOW-ENERGY, (INCLUDING PADDLES) LDD PHYSIO-CONTROL, INC 20

    Patients

    Seq Age Sex Outcome Treatment
    1