FDA Adverse Event
Death
Summary report: N
DYNASCOPE D5-3300 TELEMETRY SYSTEM ETR
MDR report key: 332986
·
Received April 19, 2001
Report
- Report Number
- 9611031-2001-00001
- Event Type
- Death
- Date Received
- April 19, 2001
- Date of Event
- April 9, 2001
- Report Date
- April 19, 2001
- 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 APRIL 19TH 2001 THE HOSPITAL MAILED A COPY OF THEIR MEDWATCH FORM, (RECEIVED ON 4/24/01). DESCRIBED EVENT WAS, PATIENT FOUND UNRESPONSIVE. FULL CODE CALLED. RESUSCITATION EFFORT UNSUCCESSFUL.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 18488 | DYNASCOPE D5-3300 TELEMETRY SYSTEM ETR | TELEMETRY CENTRAL STATION | DSI | FUKUDA DENSHI CO. LTD | DS-3300 | * |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 76 YR | Death |