BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BLADDER SCANNER

    MDR report key: 14799259 · Received June 24, 2022

    Report

    Report Number
    14799259
    Event Type
    Malfunction
    Date Received
    June 24, 2022
    Date of Event
    May 13, 2022
    Report Date
    June 10, 2022
    Manufacturer
    MEDA CO., LTD
    Product Code
    ITX
    UDI-DI
    06948941160008
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    RI
    Reporter Occupation
    RISK MANAGER
    Health Professional
    N

    Narratives

    Description of Event or Problem · 0

    BLADDER SCANNER WAS USED ON PATIENT TO ASSESS FOR RETENTION. BLADDER SCANNER SHOWED VOLUMES BETWEEN 600-800MLS. FOLEY WAS TO BE PLACED FOR PATIENT. WHEN FOLEY WAS PLACED THERE WAS NO OUTPUT. 3 SEPARATE NURSES ATTEMPTED TO INSERT FOLEY IN ORDER TO GET URINE OUTPUT. NURSE WENT TO CROSS REFERENCE WITH ANOTHER BLADDER SCANNER ON UNIT BEFORE UROLOGY NEEDED TO BE CONSULTED. THE SECOND BLADDER SCANNER SHOWED VOLUME OF 153.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    328869 BLADDER SCANNER TRANSDUCER, ULTRASONIC, DIAGNOSTIC ITX MEDA CO., LTD MD-6000 06948941160008

    Patients

    Seq Age Sex Outcome Treatment
    1 32485 DA Female