BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FIXED PRESSURE/FIXED FLOW REGULATOR

    MDR report key: 284821 · Received July 5, 2000

    Report

    Report Number
    2024040-2000-00002
    Event Type
    Malfunction
    Date Received
    July 5, 2000
    Date of Event
    June 5, 2000
    Report Date
    June 29, 2000
    Manufacturer
    CHAD THERAPEUTICS, INC.
    Product Code
    CAN
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    ON 06/05/2000, CHAD RECEIVED A TELEPHONE CALL FROM HOMECARE PROVIDER. THEY INFORMED THE CO THAT ONE OF THEIR PTS CALLED TO INFORM THEM THAT THE PT'S REGULATOR BLEW UP AND HIT PT IN THE CHEST. THE PROVIDER ASKED THE PT IF PT NEEDED TO SEE THE DOCTOR. THE PT STATED NO, BUT PT HAD SLIGHT PAIN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 FIXED PRESSURE/FIXED FLOW REGULATOR FR-870M REGULATOR CAN CHAD THERAPEUTICS, INC. FR-870M NA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Other