FDA Adverse Event
Other
Summary report: N
GE
MDR report key: 621507
·
Received July 1, 2005
Report
- Report Number
- 621507
- Event Type
- Other
- Date Received
- July 1, 2005
- Date of Event
- June 6, 2005
- Report Date
- July 1, 2005
- Manufacturer
- GE MEDICAL SYSTEMS
- Product Code
- ILQ
- Report Source
- User Facility report
- Reporter Location
- IL, US
Narratives
Description of Event or Problem · 1
A PATIENT CALLED TO STATE THAT WHILE HAVING AN MRI DONE, THE PATIENT WAS GIVEN A "SQUEEZE BALL" CALL LIGHT TO REQUEST STAFF. THE PATIENT BECAME FRIGHTENED IN THE MACHINE AND USED CALL LIGHT. UNFORTUNATELY, THE CALL LIGHT WAS NOT WORKING.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | GE | SQUEEZE BALL CALL LIGHT | ILQ | GE MEDICAL SYSTEMS | * | * |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 57 YR |