FDA Adverse Event
Malfunction
Summary report: N
HUDSON CONCHA NEPTUNE
MDR report key: 2093318
·
Received April 15, 2011
Report
- Report Number
- 3003898360-2011-00158
- Event Type
- Malfunction
- Date Received
- April 15, 2011
- Date of Event
- March 24, 2011
- Report Date
- March 25, 2011
- Manufacturer
- TELEFLEX MEDICAL
- Product Code
- BTT
- Removal / Correction Number
- NA
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- KY, US
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
Narratives
Additional Manufacturer Narrative · 1
PRODUCT HAS NOT BEEN RETURNED FOR INVESTIGATION AT THE TIME OF THIS REPORT. A FOLLOW-UP REPORT WILL BE SUBMITTED WHEN INVESTIGATION IS COMPLETE.
Description of Event or Problem · 1
THE EVENT IS REPORTED AS: COMPLAINT ALLEGES THE CIRCUIT MELTED WHILE ON PATIENT. IT MELTED ON THE INSPIRATORY LIMB NEAR THE MIDDLE OF THE CIRCUIT. NO PATIENT INJURY REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | HUDSON CONCHA NEPTUNE | HEATED HUMIDIFIER | BTT | TELEFLEX MEDICAL | NA | UNK |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Other |