BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PORTASCAN BLADDER SCANNER

    MDR report key: 18573941 · Received January 23, 2024

    Report

    Report Number
    MW5150684
    Event Type
    Malfunction
    Date Received
    January 23, 2024
    Date of Event
    January 9, 2024
    Report Date
    January 22, 2024
    Manufacturer
    LABORIE MEDICAL TECHNOLOGIES CORP.
    Product Code
    ITX
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    SC, US
    Reporter Occupation
    RISK MANAGER
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    PATIENT COMPLAINED OF THE NEED TO URINATE AND ATTEMPTED TO URINATE SEVERAL TIMES OVER A COUPLE HOUR PERIOD. RN USED PORTA SCAN BLADDER SCANNER TO SCAN PATIENT. SCAN CONSISTENTLY SHOWED AROUND 175ML. THE PHYSICIAN WAS AT BEDSIDE AND SCANNED THE PATIENT'S BLADDER WITH THE ULTRASOUND DEVICE WHICH READ 700. THE NURSE PLACED A FOLEY WITH 500ML URINE. A SECOND RN STATED THE SAME THING HAPPENED TO HER PATIENT, THE SCAN SHOWED 225ML AND THE ULTRASOUND READ >700. A FOLEY WAS PLACED AND 800ML OF URINE WAS IN FOLEY BAG. THIS MACHINE HAS BEEN REPAIRED 3 TIMES. EACH TIME IT IS RETURNED, WE HAVE THE SAME ISSUES. THE PROBE WAS REPORTED TO NEED REPLACEMENT. AFTER DISCUSSION, IT HAS BEEN DETERMINED THAT IT IS MORE COST EFFECTIVE TO REPLACE THE MACHINE. WE ARE OBTAINING A QUOTE FOR A REPLACEMENT. PORTASCAN BLADDER SCANNER (B)(6).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2474637 PORTASCAN BLADDER SCANNER TRANSDUCER, ULTRASONIC, DIAGNOSTIC ITX LABORIE MEDICAL TECHNOLOGIES CORP. MD6000K0613

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR Male Other