BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ASSY, PROBE, BLADDERSCAN BVI 9400/9600

    MDR report key: 2972510 · Received February 15, 2013

    Report

    Report Number
    3022472-2013-00036
    Event Type
    Malfunction
    Date Received
    February 15, 2013
    Date of Event
    January 18, 2013
    Report Date
    January 18, 2013
    Manufacturer
    VERATHON MEDICAL
    Product Code
    IYO
    PMA / PMN Number
    K071217
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    EVAL RESULTS PENDING ANALYSIS OF THE PRODUCT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE DEVICE WAS READING INACCURATELY ON EVERY PT. NO PT INJURY WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    69452 ASSY, PROBE, BLADDERSCAN BVI 9400/9600 NONE IYO VERATHON MEDICAL 0570-0188

    Patients

    Seq Age Sex Outcome Treatment
    1