FDA Adverse Event
Injury
Summary report: N
VIRIDIA 26/24 COMPONENT MONITORING SYSTEM
MDR report key: 257776
·
Received January 5, 2000
Report
- Report Number
- 1218950-2000-00001
- Event Type
- Injury
- Date Received
- January 5, 2000
- Date of Event
- December 5, 1999
- Report Date
- December 6, 1999
- Manufacturer
- AGILENT TECHNOLOGIES, INC.
- Product Code
- DRT
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- GM
- Reporter Occupation
- BIOMEDICAL ENGINEER
Narratives
Description of Event or Problem · 1
THE PT WAS CYANOTIC, BRADYCARDIC, AND HYPOTENSIVE, BUT NO ACOUSTIC ALARMS WERE RECOGNIZED EITHER ON THE MONITOR OR AT THE CENTRAL STATION. THE PT SUFFERED HYPOXEMIA WITH POSSIBLE CEREBRAL DAMAGE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | VIRIDIA 26/24 COMPONENT MONITORING SYSTEM | OMNICARE CMS | DRT | AGILENT TECHNOLOGIES, INC. | M1205A | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 78 YR | Life Threatening |