BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ULTRA DC FLOWMETER

    MDR report key: 19182230 · Received April 25, 2024

    Report

    Report Number
    2020813-2024-00001
    Event Type
    Malfunction
    Date Received
    April 25, 2024
    Date of Event
    March 22, 2024
    Report Date
    April 25, 2024
    Manufacturer
    ACCUTRON, INC.
    Product Code
    BSZ
    UDI-DI
    00813830021219
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AR, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE ULTRA DC FLOWMETER SUBJECT OF THE REPORTED EVENT IS BEING RETURNED FOR EVALUATION. INVESTIGATION OF THIS EVENT IS CURRENTLY IN PROCESS. A FOLLOW-UP REPORT WILL BE SUBMITTED WHEN ADDITIONAL INFORMATION BECOMES AVAILABLE.

    Additional Manufacturer Narrative · 0

    THE ULTRA DC FLOWMETER (SN: (B)(6) SUBJECT OF THE REPORTED EVENT HAS NOT BEEN RETURNED FOR EVALUATION.

    Description of Event or Problem · 0

    THE USER FACILITY REPORTED THAT DURING TWO PATIENT PROCEDURES INVOLVING THE ULTRA DC FLOWMETER THE PATIENTS BECAME "NAUSEOUS" AND "UNRESPONSIVE". THE PATIENTS WERE DISCHARGED AND REPORTED TO BE FINE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1541560 ULTRA DC FLOWMETER FLOWMETER BSZ ACCUTRON, INC. 31980 00813830021219

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown