BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PORTASCAN 3D BLADDER SCANNER

    MDR report key: 19414446 · Received May 29, 2024

    Report

    Report Number
    19414446
    Event Type
    Malfunction
    Date Received
    May 29, 2024
    Date of Event
    February 29, 2024
    Report Date
    February 2, 2024
    Manufacturer
    MEDA CO., LTD
    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 REPORTED THAT SHE HAD BLADDER SCANNED PATIENT WITH LABORIE PORTASCAN 3D BLADDER SCANNER. SCANNER READ MAX VOLUME OF 470ML, BUT WHEN STRAIGHT CATHETERIZED HAD 875ML OUT. INCORRECT READINGS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    594447 PORTASCAN 3D BLADDER SCANNER TRANSDUCER, ULTRASONIC, DIAGNOSTIC ITX MEDA CO., LTD MD-6000

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown