FDA Adverse Event
Malfunction
Summary report: N
ADULT INSPIRATORY HEATED BREATHING CIRCUIT
MDR report key: 1565010
·
Received November 17, 2009
Report
- Report Number
- 9611451-2009-00696
- Event Type
- Malfunction
- Date Received
- November 17, 2009
- Date of Event
- February 9, 2009
- Manufacturer
- FISHER & PAYKEL HEALTHCARE, LTD.
- Product Code
- BTT
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- KS
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
Narratives
Additional Manufacturer Narrative · 1
(B)(4): ADDITIONAL LOT NUMBER: 090421, DATE OF MANUFACTURE: 04/21/2009. THE RT212 BREATHING CIRCUIT IS NOT SOLD IN THE USA BUT IT IS SIMILAR TO A PRODUCT WHICH IS SOLD IN THE USA. THE 510 (K) FOR THAT PRODUCT IS K983112. THE RT212 BREATHING CIRCUITS ARE CURRENTLY EN ROUTE TO FISHER & PAYKEL HEALTHCARE FOR ANALYSIS. WE WILL PROVIDE A FOLLOW-UP REPORT UPON COMPLETION OF OUR INVESTIGATION.
Description of Event or Problem · 1
A HOSPITAL IN (B)(6) REPORTED THAT TWO (2) RT212 ADULT INSPIRATORY HEATED BREATHING CIRCUITS HAD FAULTY INSPIRATORY HEATER WIRE CONNECTORS. NO PT CONSEQUENCE WAS REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | ADULT INSPIRATORY HEATED BREATHING CIRCUIT | BTT | FISHER & PAYKEL HEALTHCARE, LTD. | RT212 | 090324 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |