BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PORTASCAN BLADDER SCANNER

    MDR report key: 19836973 · Received July 26, 2024

    Report

    Report Number
    19836973
    Event Type
    Malfunction
    Date Received
    July 26, 2024
    Date of Event
    March 11, 2024
    Report Date
    March 11, 2024
    Manufacturer
    LABORIE MEDICAL TECHNOLOGIES CORP.
    Product Code
    ITX
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    MN
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    ORDER TO SCAN BLADDER. PATIENT LYING FLAT AND SCANNER READ 183 ML. FOLEY CATHETER PLACED AND URINE RETURN WAS 350 ML. MUCH GREATER THAN THE 15% PLUS OR MINUS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    946363 PORTASCAN BLADDER SCANNER TRANSDUCER, ULTRASONIC, DIAGNOSTIC ITX LABORIE MEDICAL TECHNOLOGIES CORP. MD-6000

    Patients

    Seq Age Sex Outcome Treatment
    1 78 YR Female