BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIFEPAK 12 DEFIBRILLATOR/MONITOR SERIES

    MDR report key: 1060560 · Received June 12, 2008

    Report

    Report Number
    3015876-2008-00596
    Event Type
    Malfunction
    Date Received
    June 12, 2008
    Date of Event
    May 12, 2008
    Report Date
    May 14, 2008
    Manufacturer
    PHYSIO-CONTROL, INC.
    Product Code
    MKJ
    PMA / PMN Number
    K991910
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    PHYSIO-CONTROL PROVIDED CUSTOMER WITH THE PART NUMBER FOR A REPLACEMENT THERAPY CABLE. THE HOSPITAL BIOMEDICAL ENGINEERING STAFF EVALUATED THE DEVICE AFTER REPLACING THE THERAPY CABLE AND CONFIRMED PROPER DEVICE OPERATION. THE REPLACED THERAPY CABLE WILL NOT BE RETURNED TO PHYSIO-CONTROL FOR EVALUATION. THE ROOT CAUSE OF THE REPORTED PROBLEM CANNOT BE DETERMINED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE DEVICE WOULD NOT RECOGNIZE THE THERAPY CABLE WHILE MONITORING A PATIENT. IT WAS LATER CONFIRMED BY THE CUSTOMER THAT THE PATIENT'S OUTCOME WAS NOT AFFECTED BY THIS INCIDENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LIFEPAK 12 DEFIBRILLATOR/MONITOR SERIES MKJ PHYSIO-CONTROL, INC. NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK