BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    THD DOPPLER PROBE SINGLE USE

    MDR report key: 5788820 · Received July 13, 2016

    Report

    Report Number
    3006680097-2016-00001
    Event Type
    Malfunction
    Date Received
    July 13, 2016
    Date of Event
    June 10, 2016
    Report Date
    July 8, 2016
    Manufacturer
    THD SPA
    Product Code
    JAF
    PMA / PMN Number
    K141657
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    DA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS RETURNED TO THD FOR TECHNICAL INVESTIGATION. THE PROBLEM ON THE PROBE DETECTED BY THE CUSTOMER WAS CONFIRMED. TECHNICAL INVESTIGATION ESTABLISH THAT THE ISSUE IS DUE TO A PROBLEM OF COMPATIBILITY BETWEEN THD REVOLUTION UNIT AND CRC OF THE DOPPLER PROBE. THE PROBLEM WAS NOT DETECTED DURING THE MANUFACTURING PROCESS. THE CRC IS USED TO PROPERLY IDENTIFY THE PROBE BY THE THD REVOLUTION UNIT. ACTIONS TO PREVENT FURTHER RECURRENCE OF THE ISSUE ARE GOING TO BE IMPLEMENTED. ADDITIONAL REPORT WILL BE SUMMITTED SHOULD FURTHER INFORMATION BECOME AVAILABLE.

    Description of Event or Problem · 1

    THE PROBE, WHEN CONNECTED TO A THD REVOLUTION UNIT, PROVIDED AN ERROR MESSAGE AND IT CANNOT BE USED. THE TREATMENT WAS TERMINATED WITH ANOTHER THD DEVICE WITH NO IMPACT ON PATIENT OUTCOME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    443332 THD DOPPLER PROBE SINGLE USE THD DOPPLER PROBE SINGLE USE JAF THD SPA 800063

    Patients

    Seq Age Sex Outcome Treatment
    1