BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PORTASCAN

    MDR report key: 18228718 · Received November 29, 2023

    Report

    Report Number
    18228718
    Event Type
    Malfunction
    Date Received
    November 29, 2023
    Date of Event
    July 4, 2023
    Report Date
    September 29, 2023
    Manufacturer
    LABORIE MEDICAL TECHNOLOGIES CORP
    Product Code
    ITX
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    AZ
    Reporter Occupation
    RISK MANAGER
    Health Professional
    N

    Narratives

    Description of Event or Problem · 0

    BLADDER SCANNER WAS NOT READING CORRECTLY AND THEN BEGAN READING 999 FOR EVERY SCAN AND EVERY PATIENT. BROKEN PROBE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    98019 PORTASCAN TRANSDUCER, ULTRASONIC, DIAGNOSTIC ITX LABORIE MEDICAL TECHNOLOGIES CORP

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown