BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DIGITAL ULTRA FLUSHMOUNT PACKAGE H CHAIR

    MDR report key: 18159218 · Received November 17, 2023

    Report

    Report Number
    2020813-2023-00005
    Event Type
    Malfunction
    Date Received
    November 17, 2023
    Date of Event
    September 20, 2023
    Report Date
    November 17, 2023
    Manufacturer
    ACCUTRON, INC.
    Product Code
    BSZ
    UDI-DI
    00813830024258
    PMA / PMN Number
    K052335
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE ACCUTRON DIGITAL ULTRA FLOWMETER WAS RETURNED FOR EVALUATION. DURING EVALUATION THE UNIT WAS FULLY TESTED AND NO ISSUES WERE NOTED WITH THE FUNCTION OR OPERATION OF THE DEVICE. THE REPORTED EVENT COULD NOT BE DUPLICATED. THE CUSTOMER RECEIVED A REPLACEMENT DIGITAL ULTRA FLOWMETER; NO ADDITIONAL ISSUES HAVE BEEN REPORTED.

    Additional Manufacturer Narrative · 0

    ACCUTRON HAS CONTACTED THE USER FACILITY REQUESTING THE DEVICE SUBJECT OF THE REPORTED EVENT TO BE RETURNED FOR EVALUATION. THE INVESTIGATION IN THE REPORTED EVENT IS IN PROCESS; A FOLLOW-UP MDR WILL BE SUBMITTED WHEN ADDITIONAL INFORMATION BECOMES AVAILABLE.

    Description of Event or Problem · 0

    THE USER FACILITY REPORTED THAT PATIENTS FELT TEMPORARILY DISORIENTED DURING PROCEDURES INVOLVING THE ACCUTRON DIGITAL ULTRA FLOWMETER. THE REPORTED EVENT WAS CONFIRMED TO OCCUR ON FOUR SEPARATE DATES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    913052 DIGITAL ULTRA FLUSHMOUNT PACKAGE H CHAIR FLOWMETER BSZ ACCUTRON, INC. 56800-CHAIR (10)2888127 00813830024258

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown