FDA Adverse Event
Malfunction
Summary report: N
BTT
MDR report key: 893288
·
Received August 14, 2007
Report
- Report Number
- 9611451-2007-00292
- Event Type
- Malfunction
- Date Received
- August 14, 2007
- Manufacturer
- FISHER & PAYKEL HEALTHCARE, LTD.
- Product Code
- BTT
- Product Problem
- Yes
- Report Source
- Manufacturer report
Narratives
Additional Manufacturer Narrative · 1
THE RT212 IS NOT SOLD IN THE USA BUT IT IS SIMILAR TO ANOTHER DEVICE WHICH IS SOLD IN THE USA. THE 510 (K) FOR THAT PRODUCT IS K983112. WE ARE AWAITING THE RETURN OF THE COMPLAINT DEVICE TO COMPLETE OUR INVESTIGATION.
Description of Event or Problem · 1
OUR DISTRIBUTOR IN TAIWAN RECEIVED A REPORT FROM A CUSTOMER REGARDING LEAKS FROM THE WATER TRAP OF AN RT212 BREATHING CIRCUIT. NO PT CONSEQUENCE WAS REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | BTT | BTT | FISHER & PAYKEL HEALTHCARE, LTD. | RT212 | 070123 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | YR |