FDA Adverse Event
Malfunction
Summary report: N
TELEFLEX ISIS HVT 8.0MM
MDR report key: 2934682
·
Received January 23, 2013
Report
- Report Number
- 3003898360-2013-00020
- Event Type
- Malfunction
- Date Received
- January 23, 2013
- Date of Event
- January 2, 2013
- Report Date
- January 2, 2013
- Manufacturer
- TELEFLEX
- Product Code
- BTR
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NY, US
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
Narratives
Additional Manufacturer Narrative · 1
THE LOT NUMBER OF THE DEVICE WAS UNK, THEREFORE, A DEVICE HISTORY RECORD (DHR) REVIEW COULD NOT BE PERFORMED. IT IS UNK IF THE SAMPLE IS AVAILABLE FOR RETURN. BECAUSE THE SAMPLE WAS NOT RETURNED FOR EVAL, THE COMPLAINT WAS NOT CONFIRMED AND A ROOT CAUSE COULD NOT BE ESTABLISHED.
Description of Event or Problem · 1
THE COMPLAINT IS REPORTED AS: THE TUBE OCCLUDED WITH PT SECRETIONS. THE ALLEGED INCIDENT OCCURRED WHILE THE PT WAS IN ICU AND ON A VENTILATOR WHILE USING THE NEPTUNE HEATED HUMIDIFIER.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 33320 | TELEFLEX ISIS HVT 8.0MM | ET TUBE | BTR | TELEFLEX |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NEPTUNE HEATED HUMIDIFIER |