BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIFEPAK(R) 20 DEFIBRILLATOR/MONITOR

    MDR report key: 4163651 · Received October 10, 2014

    Report

    Report Number
    3015876-2014-01196
    Event Type
    Malfunction
    Date Received
    October 10, 2014
    Date of Event
    September 15, 2014
    Report Date
    September 15, 2014
    Manufacturer
    PHYSIO-CONTROL, INC
    Product Code
    LDD
    PMA / PMN Number
    K063119
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    PHYSIO-CONTROL EXAMINED THE CUSTOMER'S DEVICE AND VERIFIED THE REPORTED ISSUE. PHYSIO THEN REPLACED BOTH THE SYSTEM CONTROLLER (SC) AND USER INTERFACE (UI) PCB ASSEMBLIES AND AFTER OBSERVING PROPER DEVICE OPERATION THROUGH FUNCTIONAL AND PERFORMANCE TESTING THE UNIT WAS RETURNED TO THE CUSTOMER FOR USE.

    Additional Manufacturer Narrative · 1

    (B)(4). PHYSIO-CONTROL CONTINUES TO INVESTIGATE THE REPORTED FAILURE AND WILL SUBMIT A SUPPLEMENTAL REPORT ON THIS EVENT TO THE FDA AS PROVIDED BY 21 CFR 803.56.

    Additional Manufacturer Narrative · 1

    PHYSIO-CONTROL EXAMINED THE REMOVED SYSTEM CONTROLLER PCB ASSEMBLY AND DETERMINED THAT THE CAUSE OF THE REPORTED ISSUE WAS AN INTEGRATED CIRCUIT (IC) CHIP, DESIGNATOR U61. THE REMOVED USER INTERFACE PCB ASSEMBLY WAS AN ANCILLARY PART AND THERE WAS NO FAILURE OF THE ASSEMBLY.

    Description of Event or Problem · 1

    THE CUSTOMER CONTACTED PHYSIO-CONTROL TO REPORT THAT WHEN ATTEMPTING TO POWER ON THEIR DEVICE IT LOCKED UP WITH A WHITE DISPLAY. THERE WAS NO PATIENT USE ASSOCIATED WITH THE REPORTED EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    640378 LIFEPAK(R) 20 DEFIBRILLATOR/MONITOR DC-DEFIBRILLATOR, LOW-ENERGY, (INCLUDING PADDLES) LDD PHYSIO-CONTROL, INC 20

    Patients

    Seq Age Sex Outcome Treatment
    1