FDA Adverse Event
Other
Summary report: N
AISYS
MDR report key: 1011981
·
Received March 11, 2008
Report
- Report Number
- 2112667-2008-00012
- Event Type
- Other
- Date Received
- March 11, 2008
- Date of Event
- January 16, 2008
- Report Date
- March 11, 2008
- Manufacturer
- DATEX-OHMEDA INC
- Product Code
- BSZ
- PMA / PMN Number
- K061609
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- OK, US
- Reporter Occupation
- RISK MANAGER
Narratives
Additional Manufacturer Narrative · 1
NOTE: CUSTOMER IS UNSURE WHICH SPECIFIC AISYS MACHINE WAS INVOLVED IN THE REPORTED EVENT. THUS NO SERIAL # CAN BE PROVIDED AND NO DEVICE MFR DATE CAN BE PROVIDED.
Description of Event or Problem · 1
CLINICIAN REPORTEDLY FORGOT TO TURN THE VAPORIZER ON AT THE START OF A CASE, RESULTING IN PT AWARENESS. THERE WAS NOT REPORTED PT INJURY. INVESTIGATION/CONCLUSION: THE CUSTOMER INADVERTENTLY FORGOT TO TURN ON THE VAPORIZER. THE CUSTOMER HAS SINCE BEEN RE-INSERVICED ON THE USE OF THE AISYS ANESTHESIA MACHINE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | AISYS | ANESTHESIA MACHINE | BSZ | DATEX-OHMEDA INC |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 45 YR |