BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIFEPAK(R) 20 DEFIBRILLATOR/MONITOR

    MDR report key: 3140504 · Received May 31, 2013

    Report

    Report Number
    3015876-2013-00460
    Event Type
    Malfunction
    Date Received
    May 31, 2013
    Date of Event
    May 3, 2013
    Report Date
    May 3, 2013
    Manufacturer
    PHYSIO-CONTROL, INC
    Product Code
    LDD
    PMA / PMN Number
    K063119
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4): THE BIOMEDICAL ENGINEER AT THE CUSTOMER'S FACILITY CONFIRMED THAT HE VERIFIED THE REPORTED FAILURE. THE BIOMEDICAL ENGINEER REPLACED THE MAIN KEYPAD ASSEMBLY AND AFTER OBSERVING PROPER DEVICE OPERATION THROUGH FUNCTIONAL AND PERFORMANCE TESTING THE UNIT WAS PLACED BACK INTO SERVICE FOR USE.THE CAUSE OF THE REPORTED ISSUE WAS THE MAIN KEYPAD ASSEMBLY.

    Description of Event or Problem · 1

    THE CUSTOMER CONTACTED PHYSIO-CONTROL TO REPORT THAT THE ON/OFF BUTTON ON THEIR DEVICE WOULD ONLY WORK INTERMITTENTLY. THERE WAS NO PATIENT USE ASSOCIATED WITH THE REPORTED EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    241095 LIFEPAK(R) 20 DEFIBRILLATOR/MONITOR DC-DEFIBRILLATOR, LOW-ENERGY, (INCLUDING PADDLES) LDD PHYSIO-CONTROL, INC 20

    Patients

    Seq Age Sex Outcome Treatment
    1