FDA Adverse Event
Other
Summary report: N
DRAGER ANESTHESIA MACHINE
MDR report key: 2510598
·
Received March 23, 2012
Report
- Report Number
- 2510598
- Event Type
- Other
- Date Received
- March 23, 2012
- Date of Event
- March 21, 2012
- Report Date
- March 22, 2012
- Manufacturer
- DRAEGER MEDICAL
- Product Code
- BSZ
- Report Source
- User Facility report
- Reporter Location
- PA, US
- Reporter Occupation
- OTHER
Narratives
Description of Event or Problem · 1
DRAGER ANESTHESIA WAS ON LOCATION TO REPAIR ANESTHESIA MACHINE THE PREVIOUS EVENING. THE MORNING HOURS OF (B)(6) 2012, THE MACHINE OXYGEN FLOW WAS FOUND NOT WORKING EVEN THOUGH THE MACHINE PASSED ALL PRE-ANESTHESIA TESTING AND THE DIGITAL READOUT INDICATED POSITIVE FLOW. THERE WAS ZERO OXYGEN FLOW. THE PATIENT INJURY OCCURRED. A CATASTROPHIC PATIENT INJURY WAS AVERTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | DRAGER ANESTHESIA MACHINE | FABIUS GS PREMIUM | BSZ | DRAEGER MEDICAL |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 55 YR |