BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PORTASCAN BLADDER SCANNER

    MDR report key: 19836974 · Received July 26, 2024

    Report

    Report Number
    19836974
    Event Type
    Malfunction
    Date Received
    July 26, 2024
    Date of Event
    March 10, 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

    PATIENT HAD ORDER FOR A PRE- AND POST-VOID BLADDER SCAN. PRE-VOID BLADDER SCAN SHOWED 213 ML OF URINE. POST-VOID BLADDER SCAN SHOWED ANYWHERE FROM 0-745 ML OF URINE. SECOND NURSE UTILIZED SCANNER TO CHECK AND WAS ALSO GETTING MANY DIFFERENT RESULTS WITH BLADDER SCANNER. OBTAINED CLINIC BLADDER SCANNER WHICH SHOWED 0 ML OF URINE IN BLADDER POST VOID. UNABLE TO ACCURATELY ASSESS PRE/POST-VOID VOLUME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    946364 PORTASCAN BLADDER SCANNER TRANSDUCER, ULTRASONIC, DIAGNOSTIC ITX LABORIE MEDICAL TECHNOLOGIES CORP. MD-6000

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR Male