FDA Adverse Event
Injury
Summary report: N
NARKOMED
MDR report key: 1475014
·
Received September 15, 2009
Report
- Report Number
- 2510954-2009-00007
- Event Type
- Injury
- Date Received
- September 15, 2009
- Date of Event
- August 13, 2009
- Report Date
- August 17, 2009
- Manufacturer
- DRAGER MED SYS, INC. (PNC)
- Product Code
- BSZ
- PMA / PMN Number
- K980553
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- OH, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
DRAEGER HAS NOT YET BEEN GIVEN ACCESS TO THE DEVICE. WHEN THE FACILITY GRANTS DRAEGER ACCESS, THE DEVICE WILL BE EVALUATED AND THE RESULTS OF THE EVALUATION WILL BE REPORTED IN A FOLLOW UP REPORT.
Description of Event or Problem · 1
IT WAS REPORTED THAT A PT WAS UNDERGOING A PROCEDURE TO EXCISION MULTIPLE SKIN LESIONS. APPROXIMATELY 10 MINS AFTER LOCAL INFILTRATION, A FIRE OCCURRED IN THE AREA OF THE PT'S FACE. THE PT SUFFERED FIRST AND SECOND DEGREE BRUNS OF THE FACE/CHEEKS. THE PT WAS TRANSFERRED TO A HIGHER TERTIARY FACILITY.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | NARKOMED | ANESTHESIA MACHINE | BSZ | DRAGER MED SYS, INC. (PNC) | 6400 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 86 YR | Other | ELECTROSURGICAL UNIT| BIS MONITOR |