FDA Adverse Event
Death
Summary report: N
COMPONENT MONITORING SYSTEM
MDR report key: 274086
·
Received April 12, 2000
Report
- Report Number
- 1218950-2000-00013
- Event Type
- Death
- Date Received
- April 12, 2000
- Date of Event
- March 11, 2000
- Report Date
- March 14, 2000
- Manufacturer
- AGILENT TECHNOLOGIES, INC.
- Product Code
- DPS
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MN, US
- Reporter Occupation
- BIOMEDICAL ENGINEER
Narratives
Description of Event or Problem · 1
THE FOLLOWING EVENT WAS REPORTED TO MFR: THE NURSE RETURNED FROM BREAK AND SAW ONLY PACER SPIKES ON THE MONITOR. NO ALARMS WERE SOUNDING. THE PT WAS RESUSCITATED AND THE CT SCAN SHOWED NO BRAIN ACTIVITY. SUPPORT WAS WITHDRAWN. THE PT EXPIRED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | COMPONENT MONITORING SYSTEM | MONITORING SYSTEM | DPS | AGILENT TECHNOLOGIES, INC. | M1175A | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 68 YR | Death |