FDA Adverse Event
Malfunction
Summary report: N
HUDSON AQUAPAK 340 SW W/040 ADAPTOR
MDR report key: 1963579
·
Received December 20, 2010
Report
- Report Number
- 1417411-2010-00055
- Event Type
- Malfunction
- Date Received
- December 20, 2010
- Date of Event
- October 14, 2010
- Report Date
- December 8, 2010
- Manufacturer
- TELEFELX MEDICAL
- Product Code
- BTT
- Removal / Correction Number
- NA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- JA
- Reporter Occupation
- NOT APPLICABLE
Narratives
Additional Manufacturer Narrative · 1
AT THE TIME OF THIS REPORT THE DEVICE SAMPLE WAS NOT RETURNED FOR EVAL.
Description of Event or Problem · 1
THE EVENT IS REPORTED AS: THE CONNECTION AT THE YELLOW WINGNUT TO FLOW METER WAS UNSTABLE AND THERE IS AN AIR LEAK. NO PT INJURY REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | HUDSON AQUAPAK 340 SW W/040 ADAPTOR | AQUAPAK HUMIDIFIER | BTT | TELEFELX MEDICAL | NA | 170107 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNK |