THD REVOLUTION
Received Jul 31, 2015 · Event occurred Jun 18, 2015
Report 3006680097-2015-00007 · MDR key 4962019
Product problems
- Communication or Transmission Problem
- Device Operates Differently Than Expected
Patient
Not reported
- No Consequences Or Impact To Patient
Narrative
Additional Manufacturer Narrative
THE DEVICE WAS RECEIVED FOR TECHNICAL INVESTIGATION. BASED ON THE PRODUCT ANALYSIS RESULTS, THE PROBABLE ROOT CAUSE OF THE FAILURE IS: A COLD SOLDER JOINT WITHIN THE DEVICE. THE ROOT CAUSE ANALYSIS ESTABLISHED THAT IN THE FINAL TESTS BEFORE THE RELEASE OF THE DEVICE FOR DISTRIBUTION, THE DOPPLER SIGNAL COULD BE REGULARLY HEARD AND NO ANOMALIES WERE FOUND. COMPLAINTS TREND ANALYSIS DID NOT HIGHLIGHT SIMILAR EVENTS REPORTED FOR THE SAME DEVICE. NEWLY MANUFACTURED DEVICES WILL BE MONITORED FOR FUTURE REOCCURRENCE. SHOULD WE GET FURTHER INFO, ADD'L REPORT WILL BE SUBMITTED.
Description of Event or Problem
THE THD REVOLUTION, WHEN ACTIVATED, DID NOT TRANSMIT ANY DOPPLER SIGNAL. THE TREATMENT WAS TERMINATED WITH ANOTHER DEVICE, WITH NO IMPACT ON THE PT OUTCOME.