BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SWAN- GANZ, VIP

    MDR report key: 2020672 · Received March 7, 2011

    Report

    Report Number
    2020672
    Event Type
    Malfunction
    Date Received
    March 7, 2011
    Date of Event
    February 5, 2011
    Report Date
    February 7, 2011
    Manufacturer
    EDWARDS LIFESCIENCE
    Product Code
    DYG
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    MD, US

    Narratives

    Description of Event or Problem · 1

    THE PULMONARY ARTERY CATHETER (PAC) TEMPERATURE WAS 103.8 AND DID NOT CORRELATE WITH THE PATIENT'S TEMPERATURE WHEN USING OTHER METHODS.MANUFACTURER RESPONSE FOR CATHETER, FLOW DIRECTED, SWAN-GANZ, VIP: CALLED AND LEFT DETAILED MESSAGE. WAITING FOR RESPONSE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SWAN- GANZ, VIP CATHETER, FLOW DIRECTED DYG EDWARDS LIFESCIENCE 831HF75 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR