FDA Adverse Event
Malfunction
Summary report: N
HUDSON CONCHA NEPTUNE
MDR report key: 2241082
·
Received August 17, 2011
Report
- Report Number
- 3003898360-2011-00355
- Event Type
- Malfunction
- Date Received
- August 17, 2011
- Date of Event
- August 9, 2011
- Report Date
- August 9, 2011
- Manufacturer
- TELEFLEX MEDICAL
- Product Code
- BTT
- Removal / Correction Number
- NA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CA, US
- Reporter Occupation
- NOT APPLICABLE
Narratives
Additional Manufacturer Narrative · 1
THE RESULTS OF THE INVESTIGATION ARE NOT AVAILABLE AT THE TIME OF THIS REPORT. A F/U REPORT WILL BE SUBMITTED UPON COMPLETION OF THE INVESTIGATION.
Description of Event or Problem · 1
THE EVENT IS REPORTED AS: THE UNIT CONTINUES TO OVERHEAT. THE UNIT GOES ABOVE THE PRE-SET TEMP. THE ALARM ON THE UNIT DOES ALERT USER. NO PT INJURY REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | HUDSON CONCHA NEPTUNE | HEATED HUMIDIFICATION DEVICE | BTT | TELEFLEX MEDICAL | NA | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNK |