FDA Adverse Event
Malfunction
Summary report: N
AUTOFEED HUMIDIFICATION CHAMBER
MDR report key: 1220359
·
Received October 31, 2008
Report
- Report Number
- 9611451-2008-00646
- Event Type
- Malfunction
- Date Received
- October 31, 2008
- Report Date
- October 3, 2008
- Manufacturer
- FISHER & PAYKEL HEALTHCARE, LTD.
- Product Code
- BTT
- PMA / PMN Number
- K934140
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- AS
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
Narratives
Additional Manufacturer Narrative · 1
THE DEVICE IS CURRENTLY UNDER INVESTIGATION. RESULTS OF THE INVESTIGATION WILL BE PROVIDED IN A FOLLOW-UP REPORT.
Description of Event or Problem · 1
A HEALTHCARE FACILITY IN ANOTHER COUNTRY REPORTED TO A FISHER & PAYKEL REPRESENTATIVE THAT AN AUTOFEED HUMIDIFICATION CHAMBER FILLED ABOVE THE MAXIMUM WATER LINE, DURING INITIAL APPLICATION ON THE PATIENT. THE OVERFILLING WAS NOTICED IN THE FIRST 2-5 MIN FOLLOWING APPLICATION. THE CHAMBER WAS REPLACED. NO PATIENT CONSEQUENCE WAS REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | AUTOFEED HUMIDIFICATION CHAMBER | BTT | FISHER & PAYKEL HEALTHCARE, LTD. | MR290HFV | 080807 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |