THD REVOLUTION
Received Dec 20, 2019 · Event occurred Nov 14, 2019
Report 3006680097-2019-00002 · MDR key 9504713
Product problems
- No Audible Prompt/Feedback
Patient
Not reported
- No Known Impact Or Consequence To Patient
- No Known Impact Or Consequence To Patient
Narrative
Additional Manufacturer Narrative
THE DEVICE WAS RECEIVED FOR TECHNICAL INVESTIGATION. BASED ON THE PRODUCT ANALYSIS RESULTS, THE ROOT CAUSE ANALYSIS OF THE FAILURE IS A COLD SOLDER JOINT WITHIN THE DEVICE, IN PARTICULAR OF A DOPPLER PROBE CONNECTOR WIRING CABLE. THE INVESTIGATION OF THE COMPLAINT WITH REFERENCE TO THE MANUFACTURING RECORDS FOUND THAT THE IN THE FINAL TESTS PERFORMED BEFORE THE RELEASE OF THE DEVICE FOR DISTRIBUTION, THE DOPPLER SIGNAL COULD BE REGULARLY HEARD AND NO ANOMALIES WERE FOUND. COMPLAINTS TREND ANALYSIS FOUND ONLY ONE SIMILAR EVENT OCCURRED IN 2015 FOR THE SAME DEVICE AND REPORTED WITH (MFR REPORT#3006680097-2015-007). WE EMPHASIZE THAT THE DEVICE WAS MANUFACTURED IN 2014 AND THE PROBLEM OCCURRED AFTER SEVERAL HOURS OF OPERATION OF THE DEVICE, WHICH HAD NEVER BEFORE EXPERIENCED ANY PROBLEMS. FURTHERMORE, THE DEVICE WAS MANUFACTURED BEFORE THE DATE OF THE FIRST REPORT (MFR REPORT#3006680097-2015-007), AFTER WHICH A MONITORING ACTION WAS OPENED ON ALL NEWLY PRODUCED DEVICES AND NO ANOMALIES HAVE BEEN FOUND UP TO DATE. WE THEREFORE CONSIDER THE EVENT A RARE AND ISOLATED PROBLEM. THE MONITORING ACTIVITY ON NEW DEVICES IS CARRIED OUT ROUTINELY. SHOULD WE GET FURTHER INFORMATION, ADDITIONAL REPORT WILL BE SUBMITTED.
Description of Event or Problem
NO DOPPLER SOUND CAN BE HEARD FROM THE THD REVOLUTION DURING THE OPERATION. THE STAFF THEN CHANGED THE THD SLIDE SET, BUT THEY COULD NOT HEAR ANY DOPPLER SIGNAL. THE OPERATION WAS COMPLETED WITHOUT PROBLEMS FOR THE PATIENT USING ANOTHER DEVICE.