BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MICRO A.B.G.

    MDR report key: 14228 · Received June 22, 1994

    Report

    Report Number
    MW1002551
    Event Type
    Malfunction
    Date Received
    June 22, 1994
    Report Date
    June 8, 1994
    Manufacturer
    MARQUEST MEDICAL PRODUCTS, INC.
    Product Code
    CBT
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    FL, US
    Reporter Occupation
    RESPIRATORY THERAPIST

    Narratives

    Description of Event or Problem · 1

    THE REPORTED DEFECT IS NOT USUAL FOR THE DEVICE, NOR IS THE DISCREPANCY AN EXPECTED FAILURE. A REVIEW OF THE COMPLAINT DATA BASE INDICATES TWO SIMILAR DISCREPANCIES REPORTED FOR A TOTAL OF THREE OCCURRENCES FOR A PERIOD OF TWENTY-THREE MONTHS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MICRO A.B.G. BLOOD GAS SYRINGE PACKAGE CBT MARQUEST MEDICAL PRODUCTS, INC. NA

    Patients

    Seq Age Sex Outcome Treatment
    1 * Other