FDA Adverse Event
Death
Summary report: N
FUKUDA DENSHI
MDR report key: 294905
·
Received August 31, 2000
Report
- Report Number
- 294905
- Event Type
- Death
- Date Received
- August 31, 2000
- Date of Event
- August 13, 2000
- Report Date
- August 30, 2000
- Manufacturer
- MEDIQ/PRN
- Product Code
- DSI
- Adverse Event
- Yes
- Report Source
- User Facility report
- Reporter Location
- TX, US
- Reporter Occupation
- OTHER
Narratives
Description of Event or Problem · 1
RENTED TELEMETRY UNIT PICKED UP LOTS OF INTERFERENCE. WHEN NURSE WENT TO CHECK ON PT, PT FOUND UNCONSCIOUS, WITHOUT PULSE. CODED, BUT TO NO AVAIL. EQUIPMENT FAILED TO NOTIFY STAFF OF ABNORMAL OCCURRENCE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | FUKUDA DENSHI | TELEMETRY MONITOR DYNA SCOPE DS-3300 | DSI | MEDIQ/PRN | AU-3310 | * |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 82 YR | Death |