BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIFEPAK 9 DEFIBRILLATOR/MONITOR

    MDR report key: 1172011 · Received September 18, 2008

    Report

    Report Number
    3015876-2008-01199
    Event Type
    Malfunction
    Date Received
    September 18, 2008
    Date of Event
    August 20, 2008
    Report Date
    August 20, 2008
    Manufacturer
    PHYSIO-CONTROL, INC.
    Product Code
    LDD
    PMA / PMN Number
    K881153
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    THE CUSTOMER'S BIO-MEDICAL ENGINEER REPLACED THE IC CHIP, DESIGNATOR U28, RESOLVING THE ISSUE. THE DEVICE WAS RE-CALIBRATED AND PLACED BACK INTO SERVICE. THE REPLACED IC CHIP WILL NOT BE RETURNED TO PHYSIO-CONTROL FOR EVALUATION. THE ROOT CAUSE OF THE REPORTED FAILURE CANNOT BE DETERMINED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A DEVICE'S DEFIBRILLATION ENERGY DELIVERY WAS INCORRECT. THERE WERE NO REPORTS OF PATIENT USE ASSOCIATED WITH THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LIFEPAK 9 DEFIBRILLATOR/MONITOR LDD PHYSIO-CONTROL, INC. 9 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 NA