FDA Adverse Event
Summary report: N
SKYTRON 6500HD
MDR report key: 1932243
·
Received November 29, 2010
Report
- Report Number
- 1932243
- Date Received
- November 29, 2010
- Date of Event
- November 15, 2010
- Report Date
- November 29, 2010
- Manufacturer
- SKYTRON
- Product Code
- GDC
- Report Source
- User Facility report
- Reporter Location
- MD, US
Narratives
Description of Event or Problem · 1
SURGICAL BED MALFUNCTION. PATIENT WAS SUPINE AND IN SKULL PINS. THE BED SUDDENLY WENT INTO REFLEX WITHOUT ANYONE TOUCHING IT.====================== HEALTH PROFESSIONAL'S IMPRESSION======================POTENTIAL FOR PATIENT HARM DURING SURGERY. NO HARM WAS DONE, AND THE BED WAS SEQUESTERED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | SKYTRON 6500HD | OPERATING ROOM TABLE | GDC | SKYTRON | 6500 HD | * |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 78 YR |