FDA Adverse Event
Death
Summary report: N
FUKUDA DENSHI MODEL LX-3100
MDR report key: 290972
·
Received August 14, 2000
Report
- Report Number
- 9611031-2000-00003
- Event Type
- Death
- Date Received
- August 14, 2000
- Date of Event
- May 27, 2000
- Report Date
- August 11, 2000
- Manufacturer
- FUKUDA DENSHI CO., LTD.
- Product Code
- DSI
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- KY, US
- Reporter Occupation
- OTHER
Narratives
Description of Event or Problem · 1
ON 07/10/2000, THE HOSP FORWARDED A COPY OF MEDWATCH FORM. THE DESCRIPTION ON FORM WAS "PT ON TELEMETRY FOUND PULSELESS WITH NO RESPIRATION. POSSIBLE MISSED CONNECTION BETWEEN TERMINAL BOX AND CABLE."
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | FUKUDA DENSHI MODEL LX-3100 | TELEMETRY TRANSMITTER | DSI | FUKUDA DENSHI CO., LTD. | LX-3100 | * |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 67 YR | Death |