FDA Adverse Event
Summary report: N
HANA OPERATING ROOM TABLE
MDR report key: 2061188
·
Received March 16, 2011
Report
- Report Number
- 2921578-2011-00010
- Date Received
- March 16, 2011
- Date of Event
- February 28, 2011
- Report Date
- March 15, 2011
- Manufacturer
- MIZUHO ORTHOPEDIC SYSTEMS, INC.
- Product Code
- JEA
- Report Source
- Manufacturer report
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
FAILURE TO BE EVALUATED AND WILL ADVISE UPON RECEIPT.
Description of Event or Problem · 1
PREPARING FOR PT TRANSFER, LEG WAS PLACED IN SUPPORT ONTO LEG SPAR. HEALTHCARE WORKER PULLED PERINEAL POST FROM TABLE AND DID NOT SLIDE PT BACK. THE HEALTHCARE WORKER WAS NOT SURE IF LEG SPAR WAS LOCKED IN PLACE. LEG FELL TO FLOOR AND PT FELL FROM TABLE. PT HIT FLOOR HIT SHOULDER AND HEAD ON GROUND. A CAT SCAN WAS ORDERED, AND PT IS IN ICU ON VENTILATOR.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | HANA OPERATING ROOM TABLE | OPERATING ROOM TABLE | JEA | MIZUHO ORTHOPEDIC SYSTEMS, INC. | 6875 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 70 YR |