BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OXYTOTE

    MDR report key: 19219953 · Received May 1, 2024

    Report

    Report Number
    19219953
    Event Type
    Malfunction
    Date Received
    May 1, 2024
    Date of Event
    April 4, 2024
    Report Date
    April 18, 2024
    Manufacturer
    WESTERN/SCOTT FETZER COMPANY
    Product Code
    CAN
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    CT
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    EVENT 1: TANK FOUND ON FLOOR WITH A PSI READING OF 2705. PROBLEM WITH TANKS REGULATOR SHOWING INCORRECT PSI READING. TANK WAS FLAGGED AND SENT BACK TO (B)(4). EVENT 2: TANK FOUND IN X-RAY READING HHHH. BAD REGULATOR. TANK TAKEN OUT OF SERVICE, TAGGED AND SENT BACK TO (B)(4). EVENT 3: NEW TANK CAME IN WITH A PSI READING OF 2285. PROBLEM WITH TANKS REGULATOR SHOWING INCORRECT PSI READING. TANK WAS FLAGGED AND SENT BACK TO (B)(4). EVENT 4: NEW TANK CAME IN WITH A PSI READING OF 2396. PROBLEM WITH TANKS REGULATOR SHOWING INCORRECT PSI READING. TANK WAS FLAGGED AND SENT BACK TO ALLGAS. MANUFACTURER RESPONSE FOR OXYTOTE, OXYTOTE (PER SITE REPORTER): ONGOING ISSUE AND DISCUSSION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2138247 OXYTOTE REGULATOR, PRESSURE, GAS CYLINDER CAN WESTERN/SCOTT FETZER COMPANY

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown