FDA Adverse Event
Other
Summary report: N
8010652-2008-00001
MDR report key: 1003720
·
Received February 7, 2008
Report
- Report Number
- 8010652-2008-00001
- Event Type
- Other
- Date Received
- February 7, 2008
- Product Code
- FQO
- Report Source
- Manufacturer report
Narratives
Additional Manufacturer Narrative · 1
AFTER REPORT OF INCIDENT, A SERVICE TECHNICIAN WENT TO THE CUSTOMER SITE AND EVALUATED THE TABLE. THE TECHNICIAN VERIFIED WITH THE HOSP STAFF THAT NO INJURY HAD OCCURRED, AND THEN CONDUCTED AN EVAL OF THE TABLE. THE TECHNICIAN TESTED ALL TABLE FUNCTIONALITY. THE PERFORMANCE WAS INITIALLY EVALUATED WITH NO WEIGHT ON THE TOP OF THE TABLE. THEN TO SIMULATE USAGE, THE SAME EVAL WAS PERFORMED WITH WEIGHT PLACED UPON THE TABLE TOP. THE TECHNICIAN WAS NOT ABLE TO DUPLICATE THE INCIDENT DESCRIBED BY THE FACILITY. THE TECHNICIAN VERIFIED ALL FLUID LEVELS, CHECKED THE HYDRAULIC CYLINDERS FOR LEAKS AND EVALUATED ELECTRICAL COMPONENTS. AGAIN, NO CAUSE FOR THE DROP COULD BE IDENTIFIED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | FQO |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |