FDA Adverse Event
Death
Summary report: N
GENERAL ELECTRIC MEDICAL SYSTEMS
MDR report key: 340457
·
Received July 2, 2001
Report
- Report Number
- MW1022322
- Event Type
- Death
- Date Received
- July 2, 2001
- Date of Event
- June 12, 2001
- Report Date
- July 2, 2001
- Manufacturer
- GENERAL ELECTRIC MEDICAL SYSTEMS
- Product Code
- FQO
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Voluntary report
- Reporter Location
- CA, US
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
Narratives
Description of Event or Problem · 1
PT JUST COMPLETED PTCA PROCEDURE, REQUESTED BED PAN AND ROLLED OFF TABLE DURING PLACEMENT OF BED PAN. FALL RESULTED IN RUPTURED SPLEEN, BROKEN RIBS AND SUBDURAL HEMATOMA, PT DIED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 29919 | GENERAL ELECTRIC MEDICAL SYSTEMS | OMEGA IV ANGIO STEP OPERATING TABLE | FQO | GENERAL ELECTRIC MEDICAL SYSTEMS | ANGIO STEP | * |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 81 YR | Death |