BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DEROYAL

    MDR report key: 3963933 · Received May 22, 2014

    Report

    Report Number
    3005011024-2014-00005
    Event Type
    Malfunction
    Date Received
    May 22, 2014
    Date of Event
    April 24, 2014
    Report Date
    May 1, 2014
    Manufacturer
    DEROYAL INDUSTRIES, INC.
    Product Code
    KDD
    PMA / PMN Number
    K884823
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DEROYAL: THE REPORTED DEVICE HAS NOT BEEN RETURNED TO DEROYAL AT THIS TIME. THE TRANSDUCER IS MANUFACTURED BY ICU MEDICAL. THEY HAVE BEEN NOTIFIED OF THE ISSUE AND INVESTIGATION IS IN PROCESS TO DETERMINE THE ROOT CAUSE.

    Description of Event or Problem · 1

    THE HOSPITAL REPORTED THAT THE TRANSDUCER STOPPED WORKING AND CAN NOT GET PRESSURE. THE TRANSDUCER HAD TO BE REPLACED TO CONTINUE THE PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    304237 DEROYAL KIT, SURGICAL INSTRUMENT, DISPOSABLE KDD DEROYAL INDUSTRIES, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention