BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PORTASCANNER

    MDR report key: 19728830 · Received July 12, 2024

    Report

    Report Number
    19728830
    Event Type
    Malfunction
    Date Received
    July 12, 2024
    Date of Event
    February 20, 2024
    Report Date
    February 22, 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

    NURSE SCANNED PATIENT¿S BLADDER WITH 2MS LABORIE PORTASCAN BLADDER SCANNER WITH LARGEST VOLUME READING OF 569 ML AFTER 5 SCANS. NURSE FOLLOWED INSTRUCTIONS AND TIPS/TRICKS INCLUDING GOLF BALL SIZE AMOUNT OF GEL AND APPLIED FIRM STEADY PRESSURE WHILE ALL 12 IMAGES WERE TAKEN. PATIENT WAS STRAIGHT CATHETERIZED FOR A VOLUME OF 700ML. UNIT WAS EVALUATED BY HOSPITAL TECHNOLOGY TECHNICIAN WITH THIS CONCLUSION: UNIT IN GOOD PHYSICAL CONDITION, TESTED WITH BLADDER PHANTOM MULTIPLE TIMES AND WAS ALWAYS WITHIN THE +-15% TOLERANCE OF THE PHANTOM'S 130ML.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    275300 PORTASCANNER TRANSDUCER, ULTRASONIC, DIAGNOSTIC ITX LABORIE MEDICAL TECHNOLOGIES CORP. MD-6000

    Patients

    Seq Age Sex Outcome Treatment
    1 78 YR Female