FDA Adverse Event
Other
Summary report: N
GENERAL ANESTHESIA SYSTEM
MDR report key: 81722
·
Received April 3, 1997
Report
- Report Number
- 2242551-1997-00018
- Event Type
- Other
- Date Received
- April 3, 1997
- Date of Event
- March 3, 1997
- Report Date
- March 4, 1997
- Manufacturer
- VITAL SIGNS, INC.
- Product Code
- CAH
- Removal / Correction Number
- NA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- TX, US
- Reporter Occupation
- OTHER
Narratives
Description of Event or Problem · 1
CIRCUIT TUBING CONTAINS A "HOLE". LOOKS LIKE THE TUBING WAS CREASED AND THEN MELTED CAUSING THE "HOLES". THE PT'S CO2 LEVELS DROPPED BUT NO LONG TERM OR 'SIGNIFICANT" DANGER.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | GENERAL ANESTHESIA SYSTEM | ADULT BREATHING CIRCUIT W/CONNECTOR WYE PIECE | CAH | VITAL SIGNS, INC. | NA | 006X |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNKNOWN | Other |