THD DOPPLER PROBE SINGLE USE
Received Jul 13, 2016 · Event occurred Jun 10, 2016
Report 3006680097-2016-00001 · MDR key 5788820
Product problems
- Device Displays Incorrect Message
Patient
Not reported
- No Consequences Or Impact To Patient
- No Consequences Or Impact To Patient
Narrative
Additional Manufacturer Narrative
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
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.