FDA Adverse Event
Malfunction
Summary report: N
DUAL AIRWAY TEMPERATURE/FLOW PROBE
MDR report key: 1220361
·
Received October 31, 2008
Report
- Report Number
- 9611451-2008-00644
- Event Type
- Malfunction
- Date Received
- October 31, 2008
- Date of Event
- September 26, 2008
- Report Date
- September 26, 2008
- Manufacturer
- FISHER & PAYKEL HEALTHCARE, LTD.
- Product Code
- BTT
- PMA / PMN Number
- K983112
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- WY, US
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
Narratives
Additional Manufacturer Narrative · 1
THE DEVICE CURRENTLY EN ROUTE TO FISHER & PAYKEL HEALTHCARE 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 HOSPITAL REPORTED VIA OUR DISTRIBUTOR THAT THE TEMPERATURE/FLOW PROBE WAS "INCONSISTENT" IN THAT THE PART WAS GIVING FAULTY READINGS. NO PATIENT CONSEQUENCE WAS REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | DUAL AIRWAY TEMPERATURE/FLOW PROBE | BTT | FISHER & PAYKEL HEALTHCARE, LTD. | 900MR869 | 070809 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | FISHER & PAYKEL HEALTHCARE| MR850 RESPIRATORY HUMIDIFIER |