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.