BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PENTAPARE QRS THERMODILUTION CATHETER

    MDR report key: 16302 · Received September 21, 1994

    Report

    Report Number
    MW1003465
    Event Type
    Malfunction
    Date Received
    September 21, 1994
    Date of Event
    July 28, 1994
    Report Date
    August 10, 1994
    Manufacturer
    VIGGO SPECTRAMED
    Product Code
    DYG
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    TN, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    PULMONARY ARTERY CATHETER INSERTED ON 7/28/94. COULD NOT OBTAIN CARDIAC OUTPUT. MONITOR READ "UNKNOWN CATHETER." TROUBLESHOOTING DONE BY PHONE WITH ANOTHER MFR WHO SUGGESTED PROBLEM WITH THERMISTOR OR CARDIAC OUTPUT SETUP. SETUP CHANGED FROM CATHETER TO BAG WITHOUT RESULTS. PULMONARY ARTERY CATHETER CHANGED 7/29 VERIFYING DEFECTIVE THERMISTOR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PENTAPARE QRS THERMODILUTION CATHETER PULMONARY ARTERY CATHETER DYG VIGGO SPECTRAMED SP5537H

    Patients

    Seq Age Sex Outcome Treatment
    1 86 YR Other