BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ASSY, PROBE, BLADDERSCAN BVI 9400/9600

    MDR report key: 2972519 · Received February 15, 2013

    Report

    Report Number
    3022472-2013-00039
    Event Type
    Malfunction
    Date Received
    February 15, 2013
    Date of Event
    January 18, 2013
    Report Date
    January 18, 2013
    Manufacturer
    VERATHON INCORPORATED
    Product Code
    ITX
    PMA / PMN Number
    K071217
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    THE REPORTED ISSUE WAS NOT CONFIRMED. THE SERVICE REPRESENTATIVE DID NOT DUPLICATE THE PROBE READING ZERO. HOWEVER, HE FOUND THAT THE PROBE DIDN'T SCAN, THE DCM FAILED, AND THE J7 ON THE PROBE PCBA WAS DAMAGED. ALSO, THE SCAN CABLE FAILED THE CABLE TEST, POSSIBLY CAUSING THE PROBE INTERMITTENTLY READING ZERO. THE SERVICE REP REPLACED THE FAULTY DCM, PROBE PCBA, AND SCAN CABLE. THE SYSTEM OPERATES AS INTENDED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PROBE READ ZERO ON EVERY SCAN. THIS OCCURRED DURING USE ON MULTIPLE PATIENT'S AND BY MULTIPLE USERS. NO PATIENT INJURY WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    69367 ASSY, PROBE, BLADDERSCAN BVI 9400/9600 NONE ITX VERATHON INCORPORATED 0570-0188

    Patients

    Seq Age Sex Outcome Treatment
    1