BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BBS REVOLUTION

    MDR report key: 22519060 · Received July 16, 2025

    Report

    Report Number
    22519060
    Event Type
    Malfunction
    Date Received
    July 16, 2025
    Date of Event
    June 25, 2025
    Report Date
    July 10, 2025
    Manufacturer
    DBMEDX, INC.
    Product Code
    IYO
    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

    EXAMPLE #1: BLADDER SCANNER RESULTS APPEAR INACCURATE. PT HAVING URINARY URGENCY AND RETENTION (CHRONIC AND ACUTE). IMPORTANT TO MONITOR RESIDUAL BLADDER VOLUMES TO ASSESS PATIENT CONDITION AND CURRENT TREATMENT PLAN. ORDER TO STRAIGHT CATHETERIZE PATIENT IF POST VOID RESIDUAL GREATER THAN 400ML. NO STRAIGHT CATHS HAVE BEEN PERFORMED AS BLADDER SCANNER READER HAS NOT RESULTED IN A PVR [POST-VOID RESIDUAL] GREATER THAN 400ML. ALL READINGS FROM BLADDER SCAN HAVE BEEN LESS THAN 200ML. PT SHOWING SYMPTOMS OF INCREASED RESTLESSNESS, BLADDER SPASMS, PAIN AND SIGNS OF URINARY RETENTION. BLADDER SCAN SHOWED 32ML IN BLADDER AT 2300 [DATE REDACTED]. MULTIPLE PERSONS, MULTIPLE SCANS AND TROUBLESHOOTING TO ENSURE PROPER USE OF BLADDER SCAN. MD AWARE. PT WAS STRAIGHT CATHED WITH 300ML OUTPUT, INSTANT RELIEF OF SYMPTOMS AND PAIN. EXAMPLE #2: BLADDER SCANNER IS PRODUCING INACCURATE READINGS, DELAYED TREATMENT OF URINARY RETENTION. BLADDER SCANNED 434 CCS OF URINE AT 20:13 AND AT 22:06 BLADDER SCANNER SHOWED 284 CCS OF URINE. RN AGAIN RESCANNED AT 22:20 AND FOUND 461 CC'S OF URINE. RN STRAIGHT CATH-ED PATIENT AT 22:20 AND 1,100 CC'S OF URINE WAS FOUND IN THE BLADDER. SHOWING A HUGE DIFFERENCE. RECAP: IT APPEARS THERE IS WIDESPREAD FRUSTRATION ACROSS THE ORGANIZATION WITH THE PERFORMANCE OF THE SCANNERS, PARTICULARLY AROUND ACCURACY AND RELIABILITY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    151278 BBS REVOLUTION SYSTEM, IMAGING, PULSED ECHO, ULTRASONIC IYO DBMEDX, INC. PD-020-0019

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown