FDA Adverse Event
Malfunction
Summary report: N
NONE
MDR report key: 1001390
·
Received February 23, 2008
Report
- Report Number
- 9611451-2008-00061
- Event Type
- Malfunction
- Date Received
- February 23, 2008
- Report Date
- January 24, 2008
- Manufacturer
- FISHER & PAYKEL HEALTHCARE LTD.
- Product Code
- BTT
- PMA / PMN Number
- K983112
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- AS
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
THE BREATHING CIRCUIT IS NOT AVAILABLE IN USA. THE EQUIVALENT DEVICE FOR THE USA IS THE DEVICE THAT CONSISTS OF THE HUMIDIFICATION CHAMBER, THE INSPIRATORY LIMB OF THE BREATHING CIRCUIT, AND THE ADULT VERSION OF AN EVAQUA EXPIRATORY LIMB. THE DEVICE IS EXPECTED TO BE RETURNED TO FISHER AND PAYKEL HEALTHCARE. NO INFO TO DATE. RESULTS: INVESTIGATION STILL UNDERWAY, NO RESULTS TO DATE. CONCLUSIONS: NO CONCLUSION CAN BE MADE AT THIS TIME. OUR MONITORING AND TRENDING FOR THIS TYPE OF EVENT HAS A RATE OF OCCURRENCE WORLDWIDE FOR THE LAST YEAR OF 0.016%.
Description of Event or Problem · 1
A HOSPITAL REPORTED THAT A ADULT BREATHING CIRCUIT FAILED THE LEAK TEST. NO PT CONSEQUENCE WAS REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | NONE | BTT | FISHER & PAYKEL HEALTHCARE LTD. | RT340 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |