BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ASSY, PROBE, BLADDERSCAN BVI 9400/9600

    MDR report key: 2961272 · Received February 8, 2013

    Report

    Report Number
    3022472-2013-00010
    Event Type
    Malfunction
    Date Received
    February 8, 2013
    Date of Event
    January 10, 2013
    Report Date
    January 10, 2013
    Manufacturer
    VERATHON MEDICAL
    Product Code
    ITX
    PMA / PMN Number
    K071217
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    IMMEDIATE VISUAL DAMAGE SHOWED THE PROBE HEAD WAS CRACKED AND LEAKING OIL. THIS IS POSSIBLE CUSTOMER DAMAGE. ALSO, TROUBLESHOOTING FOUND THAT THE REPORTED ISSUE WAS CONFIRMED. THE DEVICE HAD INACCURATE SCANS BY PRESSING THE PROBE'S SCAN BUTTON. THE DCM AND PROBE'S PCB WERE REPLACED. THE SYSTEM OPERATES AS INTENDED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE UNIT READ 0ML ON EVERY PT. NO PT INJURY WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    55114 ASSY, PROBE, BLADDERSCAN BVI 9400/9600 NONE ITX VERATHON MEDICAL 0570-0188

    Patients

    Seq Age Sex Outcome Treatment
    1