BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MARQUEST SCT 200

    MDR report key: 8354 · Received June 14, 1994

    Report

    Report Number
    8354
    Event Type
    Malfunction
    Date Received
    June 14, 1994
    Date of Event
    June 5, 1994
    Report Date
    June 9, 1994
    Manufacturer
    MARQUEST MEDICAL, INC.
    Product Code
    CBK
    Product Problem
    Yes
    Report Source
    User Facility report

    Narratives

    Description of Event or Problem · 1

    PT WAS ON VENTILATOR FROM 6/4/94 TO 6/6/94. AT 1035 HOURS ON 6/5/94. NO PROBLEM NOTED WITH TEMPERATURE PROBE WHILE ON PT, BUT WHEN PROBE WAS REMOVED TO DISCARD, THE PROBE WAS MELTED INTO THE VENT OPENING.DEVICE NOT LABELED FOR SINGLE USE. PATIENT MEDICAL STATUS PRIOR TO EVENT: FAIR 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 EVALUATED AFTER THE EVENT. METHOD OF EVALUATION: VISUAL EXAMINATION. RESULTS OF EVALUATION: NONE OR UNKNOWN. CONCLUSION: DEVICE FAILED JUST PRIOR TO USE, DEVICE FAILURE OCCURRED BUT NOT RELATED TO EVENT, OTHER. CERTAINTY OF DEVICE AS CAUSE OF OR CONTRIBUTOR TO EVENT: INVALID DATA. CORRECTIVE ACTIONS: DEVICE RETURNED TO MANUFACTURER/DEALER/DISTRIBUTOR. THE DEVICE WAS NOT DESTROYED/DISPOSED OF.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MARQUEST SCT 200 VENTILATOR/HUMIDIFIER CBK MARQUEST MEDICAL, INC. NI NI

    Patients

    Seq Age Sex Outcome Treatment
    1 40 YR Other