FDA Adverse Event
Malfunction
Summary report: N
9611451-2007-00339
MDR report key: 917198
·
Received September 22, 2007
Report
- Report Number
- 9611451-2007-00339
- Event Type
- Malfunction
- Date Received
- September 22, 2007
- Date of Event
- March 26, 2007
- Report Date
- August 21, 2007
- Manufacturer
- FISHER & PAYKEL HEALTHCARE, LTD.
- Product Code
- BTT
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- JA
- Reporter Occupation
- UNKNOWN
Narratives
Additional Manufacturer Narrative · 1
THIS REPORT WAS PREPARED BY R MONEY. THIS IS A MALFUNCTION THAT HAS BEEN REPORTED TO FISHER & PAYKEL HEALTHCARE BY A HOSPITAL IN ANOTHER COUNTRY. THE PRODUCT 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.
Description of Event or Problem · 1
A HOSPITAL IN ANOTHER COUNTRY, REPORTED TO OUR DISTRIBUTOR THAT WHEN STAFF WERE SETTING UP AN RT206 BREATHING CIRCUIT TO A VENTILATOR, THEY FOUND IT LEAKED AROUND THE WATER TRAP. THE ALLEGED THAT THE PROBLEM WAS RESOLVED WHEN THE WATER TRAP WAS REPLACED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | BTT | FISHER & PAYKEL HEALTHCARE, LTD. | RT206 | 061109 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | YR |