FDA Adverse Event
Death
Summary report: N
ACUITY CENTRAL STATION
MDR report key: 478334
·
Received August 15, 2003
Report
- Report Number
- 3023750-2003-00004
- Event Type
- Death
- Date Received
- August 15, 2003
- Date of Event
- June 30, 2003
- Report Date
- July 15, 2003
- Manufacturer
- WELCH ALLYN PROTOCOL, INC.
- Product Code
- DRT
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CA, US
- Reporter Occupation
- NURSE
Narratives
Description of Event or Problem · 1
CUSTOMER REPORTED AN EVENT IN 7/2003 TO THE MANUFACTURER WHERE THEY QUESTIONED THE PERFORMANCE OF THE CENTRAL MONITORING SYSTEM.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | ACUITY CENTRAL STATION | CARDIAC MONITOR | DRT | WELCH ALLYN PROTOCOL, INC. | CENTRAL STATION | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NO INFO | Death |