FDA Adverse Event
Death
Summary report: N
ECG MONITORING SYSTEM
MDR report key: 13260
·
Received February 9, 1994
Report
- Report Number
- 13260
- Event Type
- Death
- Date Received
- February 9, 1994
- Date of Event
- December 28, 1993
- Report Date
- January 28, 1994
- Manufacturer
- MARQUETTE ELECTRONIC, INC.
- Product Code
- DPS
- Adverse Event
- Yes
- Report Source
- User Facility report
- Reporter Location
- OH, US
- Reporter Occupation
- INVALID DATA
Narratives
Description of Event or Problem · 1
PT WENT INTO VENTRICULAR FIBRILLATION AND ALTHOUGH ALARM FUNCTIONED, IT WAS NOT APPRECIATED BY STAFF SINCE THERE IS NO AUDIBLE ALARM ABLE TO BE FORWARDED AND THE VISUAL ALARM WAS NOT SUFFICIENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | ECG MONITORING SYSTEM | ECG MONITORING SYSTEM | DPS | MARQUETTE ELECTRONIC, INC. |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | * | Death |