FDA Adverse Event
Malfunction
Summary report: N
THD REVOLUTION
MDR report key: 4962019
·
Received July 31, 2015
Report
- Report Number
- 3006680097-2015-00007
- Event Type
- Malfunction
- Date Received
- July 31, 2015
- Date of Event
- June 18, 2015
- Report Date
- July 30, 2015
- Manufacturer
- THD SPA
- Product Code
- JAF
- PMA / PMN Number
- K141657
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
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 · 1
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.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 502005 | THD REVOLUTION | THD REVOLUTION | JAF | THD SPA | 700017 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |