BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    THD EVOLUTION US

    MDR report key: 4281164 · Received November 6, 2014

    Report

    Report Number
    3006680097-2014-00005
    Event Type
    Malfunction
    Date Received
    November 6, 2014
    Date of Event
    October 2, 2014
    Report Date
    November 5, 2014
    Manufacturer
    THD SPA
    Product Code
    JAF
    PMA / PMN Number
    K070815
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THE THD EVOLUTION USED DURING THE REPORTED CASES WAS RECEIVED ON 11/05/2014 IN THD (B)(4) FOR TECHNICAL INVESTIGATION. VISUAL INSPECTION, DID NOT IDENTIFY ANY DEFECTS. THE TECHNICAL INVESTIGATION COULD NOT BE COMPLETED WITHIN THE 30-DAY REPORTABILITY TIME FRAME. ADD'L INFO COULD BE PROVIDED UPON COMPLETION OF THE TECHNICAL INVESTIGATION.

    Description of Event or Problem · 1

    THE HOSP CALLED THE THD SPECIALIST ABOUT A VERY SHRILL SOUND THEIR THD EVOLUTION DEVICE WAS MAKING DURING A CASE. DURING THE FOLLOWING SCHEDULED THD CASE, THE THD EVOLUTION MACHINE HAD THE SAME PROBLEM. THEY USED ANOTHER THD EVOLUTION DEVICE AND THE CASE WAS COMPLETED SUCCESSFULLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    714273 THD EVOLUTION US NONE JAF THD SPA 700016A

    Patients

    Seq Age Sex Outcome Treatment
    1