FDA Adverse Event
Malfunction
Summary report: N
INFANT BIAS FLOW BREATHING CIRCUIT
MDR report key: 1346970
·
Received February 9, 2009
Report
- Report Number
- 9611451-2009-00055
- Event Type
- Malfunction
- Date Received
- February 9, 2009
- Date of Event
- December 5, 2008
- Report Date
- January 12, 2009
- Manufacturer
- FISHER & PAYKEL HEALTHCARE, LTD.
- Product Code
- BTT
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- JA
- Reporter Occupation
- NOT APPLICABLE
Narratives
Additional Manufacturer Narrative · 1
(B) (4). THE PRODUCT REFERRED TO IN THE EVENT DESCRIPTION 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 K20332. THE RT125 INFANT BIAS FLOW BREATHING CIRCUIT IS EN ROUTE TO FISHER & PAYKEL HEALTHCARE FOR INVESTIGATION. WE WILL PROVIDE A FOLLOW-UP REPORT UPON COMPLETION OF THE INVESTIGATION.
Description of Event or Problem · 1
A DISTRIBUTOR (B) (6) REPORTED THAT DURING THEIR INWARD GOODS INSPECTIONS, THEY FOUND A SMALL PART OF RT125 INFANT BREATHING CIRCUIT WAS MISSING. NO PT CONSEQUENCE WAS REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | INFANT BIAS FLOW BREATHING CIRCUIT | BTT | FISHER & PAYKEL HEALTHCARE, LTD. | RT125 | 080930 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |