FDA Adverse Event
Injury
Summary report: N
NARKOMED
MDR report key: 481623
·
Received September 3, 2003
Report
- Report Number
- 2517967-2003-00100
- Event Type
- Injury
- Date Received
- September 3, 2003
- Date of Event
- August 2, 2002
- Report Date
- August 27, 2003
- Manufacturer
- DRAEGER MEDICAL, INC.
- Product Code
- BSZ
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CA
- Reporter Occupation
- ATTORNEY
Narratives
Description of Event or Problem · 1
DURING A CASE, A PT UNDERGOING ORAL (DENTAL) SURGERY WAS WITHOUT OXYGEN FOR TEN TO FIFTEEN MINUTES. THE USER WAS UTILIZING SEVOFLURANE AT 6%. IT WAS REPORTED THAT THE PT HAD BRAIN ANOXIA.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | NARKOMED | ANESTHESIA MACHINE | BSZ | DRAEGER MEDICAL, INC. | 3 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 2 YR | Other |