BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OXYTOTE

    MDR report key: 19804755 · Received July 23, 2024

    Report

    Report Number
    19804755
    Event Type
    Malfunction
    Date Received
    July 23, 2024
    Date of Event
    June 7, 2024
    Report Date
    June 17, 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 [REDACTED DATE]: "NEW TANK CAME IN WITH A PSI READING OF 1724. PROBLEM WITH TANKS REGULATOR SHOWING INCORRECT PSI READING. TANK WAS FLAGGED AND SENT BACK TO (B)(4)." EVENT 2 [REDACTED DATE]: "TANK FOUND ON THE FLOOR WITH READING "HHHH" PROBLEM WITH TANKS REGULATOR. TANK WAS FLAGGED AND SENT BACK TO (B)(4)." EVENT 3 [REDACTED DATE]: "TANK SOUND WITH A PSI READING OF 2720 AND THEN FLASHING TO "OF ER". PROBLEM WITH TANKS REGULATOR. TANK WAS FLAGGED AND SENT BACK TO (B)(4)." EVENT 4 [REDACTED DATE]: "NEW TANK CAME IN WITH A PSI READING OF 2302. PROBLEM WITH TANKS REGULATOR SHOWING INCORRECT PSI READING. TANK WAS FLAGGED AND SENT BACK TO (B)(4)." MANUFACTURER RESPONSE FOR OXYTOTE TANK, OXYTOTE TANK (PER SITE REPORTER), ONGOING ISSUE WITH OXYTOTE TANKS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2479341 OXYTOTE REGULATOR, PRESSURE, GAS CYLINDER CAN WESTERN/SCOTT FETZER COMPANY MNDR-600

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown