BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ASSY, PROBE, BLADDERSCAN BVM 9500

    MDR report key: 2972613 · Received February 15, 2013

    Report

    Report Number
    3022472-2013-00020
    Event Type
    Malfunction
    Date Received
    February 15, 2013
    Date of Event
    January 18, 2013
    Report Date
    January 18, 2013
    Manufacturer
    VERATHON MEDICAL
    Product Code
    ITX
    PMA / PMN Number
    K090214
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THE REPORTED FAILURE WAS CONFIRMED. WHEN THE SCAN BUTTON WAS PRESSED, THE PROBE DISPLAYED INACCURATE SCANS. THE SCAN CABLE WAS REPLACED. ALSO, DURING THE TESTING ON THE SPIRAL PHANTOM, THE UNIT FAILED THE CALIBRATION. THE DCM WAS REPLACED. THE SYSTEM OPERATES AS INTENDED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE DEVICE DISPLAYED AN INACCURATE READING. IT WAS READING ZERO ON PATIENTS WITH POSITIVE BLADDER VOLUME RESIDUAL. NO PATIENT INJURY WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    69691 ASSY, PROBE, BLADDERSCAN BVM 9500 NONE ITX VERATHON MEDICAL 0570-0208

    Patients

    Seq Age Sex Outcome Treatment
    1