FDA Adverse Event
Death
Summary report: N
MDE ESCORT
MDR report key: 399628
·
Received June 11, 2002
Report
- Report Number
- 2022870-2002-00002
- Event Type
- Death
- Date Received
- June 11, 2002
- Date of Event
- May 28, 2002
- Report Date
- June 11, 2002
- Manufacturer
- MEDICAL DATA ELECTRONICS
- Product Code
- DRT
- Removal / Correction Number
- NA
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CO, US
- Reporter Occupation
- OTHER
Narratives
Description of Event or Problem · 1
A PT WENT INTO ASYSTOLE, WHILE CONNECTED TO A BEDSIDE MONITOR COMMUNICATING TO A CENTRAL STATION. NEITHER DEVICE ALARMED, BUT A BLINKING RED BAR APPEARED ON THE PT TILE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | MDE ESCORT | PT MONITOR | DRT | MEDICAL DATA ELECTRONICS | 20300 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNKNOWN | Death |