BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIFEPAK 20 DEFIBRILLATOR/MONITOR

    MDR report key: 1920991 · Received December 7, 2010

    Report

    Report Number
    3015876-2010-01343
    Event Type
    Malfunction
    Date Received
    December 7, 2010
    Date of Event
    November 8, 2010
    Report Date
    November 8, 2010
    Manufacturer
    PHYSIO-CONTROL, INC
    Product Code
    LDD
    PMA / PMN Number
    K012274
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4): PHYSIO- CONTROL IS ANTICIPATING THE DEVICE RETURN FOR EVAL/REPAIR AND CONTINUES TO INVESTIGATE THE REPORTED EVENT. PHYSIO WILL SUBMIT A SUPPLEMENTAL REPORT ON THIS EVENT TO THE FDA AS PROVIDED BY CFR 803.56.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT THE DEVICE HAD AN EVENT CODE THAT INDICATED A CRITICAL FAILURE IN THE MEMORY. THERE WAS NO PT USE ASSOCIATED WITH THE EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LIFEPAK 20 DEFIBRILLATOR/MONITOR LDD PHYSIO-CONTROL, INC 20 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 NA