FDA Adverse Event
Malfunction
Summary report: N
HUDSON CONCHATHERM NEPTUNE HEATED HUMIDIFIER
MDR report key: 2192926
·
Received July 22, 2011
Report
- Report Number
- 3003898360-2011-00329
- Event Type
- Malfunction
- Date Received
- July 22, 2011
- Date of Event
- July 11, 2011
- Report Date
- July 11, 2011
- Manufacturer
- TELEFLEX MEDICAL
- Product Code
- BTT
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- TX, US
- Reporter Occupation
- BIOMEDICAL ENGINEER
Narratives
Additional Manufacturer Narrative · 1
THE DEVICE SAMPLE WAS NOT RECEIVED BY THE MFR AT THE TIME OF THIS REPORT. A FOLLOW-UP REPORT WILL BE SENT IF ADDITIONAL PERTINENT INFO IS RECEIVED.
Description of Event or Problem · 1
THE EVENT IS REPORTED AS: COMPLAINT ALLEGES: "THE BLUE AND YELLOW INSPIRATORY/EXPIRATORY WIRES BURNT DUE TO CORRODED WIRES." NO PT INJURY REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | HUDSON CONCHATHERM NEPTUNE HEATED HUMIDIFIER | HEATED HUMIDIFIER | BTT | TELEFLEX MEDICAL | UNK |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNK |