FDA Adverse Event
Malfunction
Summary report: N
HUDSON COMFORT FLO HUMIDIFICATION SYSTEM
MDR report key: 2061498
·
Received March 15, 2011
Report
- Report Number
- 3004365956-2011-00107
- Event Type
- Malfunction
- Date Received
- March 15, 2011
- Date of Event
- February 18, 2011
- Report Date
- February 18, 2011
- Manufacturer
- TELEFLEX MEDICAL
- Product Code
- BTT
- Removal / Correction Number
- NA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MA, US
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
Narratives
Additional Manufacturer Narrative · 1
PRODUCT IS NOT AVAILABLE FOR EVALUATION BY MANUFACTURER. A FOLLOW-UP REPORT WILL BE SUBMITTED WHEN INVESTIGATION IS COMPLETE.
Description of Event or Problem · 1
THE EVENT IS REPORTED AS: THE CIRCUIT DISCONNECTED AT THE CUFF CAUSING A LEAK. THE CIRCUIT WAS ABLE TO BE RECONNECTED BY THE CLINICIAN AND NO PT INJURY OCCURRED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | HUDSON COMFORT FLO HUMIDIFICATION SYSTEM | COMFORT FLOW HUMIDIFICATION SYSTEM | BTT | TELEFLEX MEDICAL | NA | 02L1000243 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |