BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GOLD THERMODILUTION CATHETER

    MDR report key: 4220 · Received July 29, 1992

    Report

    Report Number
    4220
    Event Type
    Malfunction
    Date Received
    July 29, 1992
    Date of Event
    April 27, 1992
    Report Date
    May 14, 1992
    Manufacturer
    VIGGO SPECTROMED
    Product Code
    KRB
    Product Problem
    Yes
    Report Source
    User Facility report

    Narratives

    Description of Event or Problem · 1

    AFTER INSERTING PULMONARY ARTERY CATHETER, PHYSICIAN ORDERED CO/CI READINGS. HEWLETT-PACKARD MONITOR 66 WITH MODULE WAS USED WITH CATHETER. UNABLE TOGET CO/CI READINGS. NEW CATHETER INSERTEDDEVICE LABELED FOR SINGLE USE. PATIENT MEDICAL STATUS PRIOR TO EVENT: CRITICAL CONDITION. THERE WAS NOT MULTIPLE PATIENT INVOLVEMENT.INVALID DATA - ON DEVICE SERVICE/MAINTENANCE. NO DATA - REGARDING DATE LAST SERVICED. SERVICE PROVIDED BY: INVALID DATA. INVALID DATA - SERVICE RECORDS AVAILABILITY. NO IMMINENT HAZARD TO PUBLIC HEALTH CLAIMED. DEVICE USED AS LABELED/INTENDED.DEVICE WAS NOT EVALUATED AFTER THE EVENT. METHOD OF EVALUATION: NO DATA. RESULTS OF EVALUATION: NO DATA. CONCLUSION: NO DATA. CERTAINTY OF DEVICE AS CAUSE OF OR CONTRIBUTOR TO EVENT: MAYBE. CORRECTIVE ACTIONS: DEVICE DISCARDED. THE DEVICE WAS DESTROYED/DISPOSED OF.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 GOLD THERMODILUTION CATHETER PULMONARY ARTERY CATHETER KRB VIGGO SPECTROMED SP5507H 92 JAN 828

    Patients

    Seq Age Sex Outcome Treatment
    1 79 YR Other