FDA Adverse Event
Death
Summary report: N
FLEX TUBE
MDR report key: 443718
·
Received February 20, 2003
Report
- Report Number
- 2183157-2003-00011
- Event Type
- Death
- Date Received
- February 20, 2003
- Date of Event
- January 9, 2003
- Report Date
- February 20, 2003
- Manufacturer
- NELLCOR PURITAN BENNETT, INC.
- Product Code
- BZO
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MN, US
- Reporter Occupation
- NURSE
Narratives
Description of Event or Problem · 1
A NPB FLEXTUBE USED IN CONJUNCTION WITH A BI-PAP MACHINE HAD TWIST BETWEEN 180 TO 360 DEGREES CAUSING AN OCCLUSION.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | FLEX TUBE | 7" TAPERED FLEX TUBE | BZO | NELLCOR PURITAN BENNETT, INC. | L-6253 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 59 YR | Death | 1. RESPIRONICS BI-PAP,| 2. CONCHA HUMIDIFIER HEATER,| 3. LIQUID OXYGEN TANK. |