FDA Adverse Event
Death
Summary report: N
CONCHATHERM NEPTUNE HEATED HUMIDIFIER
MDR report key: 1346405
·
Received March 18, 2009
Report
- Report Number
- 3003898360-2009-00034
- Event Type
- Death
- Date Received
- March 18, 2009
- Report Date
- March 4, 2009
- Manufacturer
- TELEFLEX MEDICAL
- Product Code
- BTT
- PMA / PMN Number
- K063758
- Removal / Correction Number
- NA
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- OR, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
THE DEVICE WAS REQUESTED FOR EVALUATION, BUT WAS NOT RECEIVED AT THE TIME OF THIS REPORT. THE CUSTOMER REPORTS THAT SHE FEELS THE TELEFLEX MEDICAL SYSTEM WORKED AS IT WAS INTENDED.
Description of Event or Problem · 1
THE INCIDENT WAS REPORTED AS: THE PT WAS ON A CONCHATHERM NEPTUNE HEATER VIA A TRACH COLLAR. THE PT PULLED OUT THE TRACHEOSTOMY TUBE, AND IT WAS IDENTIFIED THAT THE TRACHEOSTOMY TUBE HAD A PLUG. THE TRACHEOSTOMY TUBE WAS REPLACED WITHOUT INCIDENT. THEN THE PT WENT INTO CARDIAC ARREST AND DNR WAS IN PLACE, SUBSEQUENTLY, THE PT DIED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | CONCHATHERM NEPTUNE HEATED HUMIDIFIER | HEATED HUMIDIFIER | BTT | TELEFLEX MEDICAL | NA | UNK |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Death |