FDA Adverse Event
Malfunction
Summary report: N
EVAQUA INFANT BREATHING CIRCUIT
MDR report key: 1061533
·
Received June 17, 2008
Report
- Report Number
- 9611451-2008-00369
- Event Type
- Malfunction
- Date Received
- June 17, 2008
- Report Date
- May 23, 2008
- Manufacturer
- FISHER & PAYKEL HEALTHCARE, LTD.
- Product Code
- BZE
- PMA / PMN Number
- K34026
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NL
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
Narratives
Additional Manufacturer Narrative · 1
THE RT235 INFANT BREATHING CIRCUIT IS CURRENT EN ROUTE TO THE MANUFACTURER FOR INVESTIGATION. NO RESULTS AND CONCLUSIONS ARE THEREFORE AVAILABLE AT PRESENT. A FOLLOW-UP REPORT WILL BE PREPARED AND FORWARDED AS SOON AS THE DEVICE HAS BEEN RETURNED AND INVESTIGATION RESULTS BECOME AVAILABLE.
Description of Event or Problem · 1
A HEALTHCARE FACILITY IN ANOTHER COUNTRY, REPORTED TO OUR DISTRIBUTOR THAT AN RT235 INFANT BREATHING CIRCUIT DID NOT PASS THE VENTILATOR LEAK TEST WHEN CONNECTED TO AN AVEA VENTILATOR DURING SET-UP. NO PATIENT CONSEQUENCE WAS REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | EVAQUA INFANT BREATHING CIRCUIT | BZE | FISHER & PAYKEL HEALTHCARE, LTD. | RT235 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | AVEA VENTILATOR |