BEUDAMED
    FDA Adverse Event Other Summary report: N

    PRECISION MEDICAL

    MDR report key: 225188 · Received May 24, 1999

    Report

    Report Number
    MW1016395
    Event Type
    Other
    Date Received
    May 24, 1999
    Date of Event
    May 6, 1999
    Report Date
    May 14, 1999
    Manufacturer
    PRECISION MEDICAL, INC.
    Product Code
    CAX
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    IA, US
    Reporter Occupation
    RESPIRATORY THERAPIST

    Narratives

    Description of Event or Problem · 1

    PT COMPLAINED OF SOB. O2 SAT 90%. OXYGEN FLOW METER HEARD LEAKING AT WALL MOUNT. ATTEMPT TO TIGHTEN METER TO WALL FAILED. WHEN COMPLETELY REMOVED FROM WALL, METER GAUGE WAS BROKEN. METER WAS CHANGED OUT. NON-LEAKING OXYGEN FLOW RESULTED. PT SPO2 AFTER THREE MINUTES 96% ON LITERS VIA NASAL CANNULA.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PRECISION MEDICAL OXYGEN FLOW METER CAX PRECISION MEDICAL, INC. 2MFA1001 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Other