FDA Adverse Event
Summary report: N
JACKSON TABLE
MDR report key: 1770088
·
Received July 22, 2010
Report
- Report Number
- 1770088
- Date Received
- July 22, 2010
- Date of Event
- April 22, 2010
- Report Date
- July 22, 2010
- Manufacturer
- MIZUHO ORTHOPEDIC SYSTEMS INC
- Product Code
- JEA
- Report Source
- User Facility report
- Reporter Location
- FL, US
- Reporter Occupation
- RISK MANAGER
Narratives
Description of Event or Problem · 1
A PATIENT WAS SUPINE AND ASLEEP ON A JACKSON SPINAL TABLE. THE PHYSICIAN WAS OPERATING ON THE PATIENT'S CERVICAL SPINE. SUDDENLY, THE JACKSON TABLE JERKED HARD AND MADE AND UP AND DOWN MOTION WITH A LOUD NOISE.====================== HEALTH PROFESSIONAL'S IMPRESSION======================THERE WAS NOT ADVERSE EVENT BUT, THE POTENTIAL FOR ONE IF THE TABLE WAS NOT STABLE DURING THE PROCEDURE. THEY SUSPECTED SOME TYPE OF MECHANICAL DEFECT IN THE LIFT SYSTEM.====================== MANUFACTURER RESPONSE FOR JACKSON STYLE OR TABLE, ORTSYS / JST2000======================MANUFACTURER COULD NOT DUPLICATE THE ISSUE OF TABLE MOVING / DROPPING ON ITS OWN.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | JACKSON TABLE | TABLE, OPERATING | JEA | MIZUHO ORTHOPEDIC SYSTEMS INC | JST2000 | * |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 52 YR |