BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ULTRASCAN B

    MDR report key: 3915630 · Received June 11, 2014

    Report

    Report Number
    2028159-2014-01115
    Event Type
    Malfunction
    Date Received
    June 11, 2014
    Date of Event
    May 13, 2014
    Report Date
    May 14, 2014
    Manufacturer
    ALCON - IRVINE TECH CTR
    Product Code
    IYO
    PMA / PMN Number
    K844686
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BR
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    INVESTIGATION INCLUDING ROOT CAUSE ANALYSIS IS IN PROGRESS. A SUPPLEMENTAL MDR WILL BE FILED AS NECESSARY IN ACCORDANCE WITH 21 CFR 803.56 WHEN ADDITIONAL REPORTABLE INFO BECOMES AVAILABLE. (B)(4).

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT DURING A BIOMETRY EXAM, THE ULTRASOUND PROBE WAS LEAKING AND PROVIDING INCORRECT MEASUREMENTS. THE EXAM WAS COMPLETED USING THE SAME EQUIPMENT AND ACCESSORY. THERE WAS NO HARM TO THE PT. ADDITIONAL INFO HAS BEEN REQUESTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    343846 ULTRASCAN B ULTRASCAN B IYO ALCON - IRVINE TECH CTR ULTRASCAN B NA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK