DEVICE #1 ADVANCED CONTROL BASE, JACKSON MODULAR TABLE SYST
Received Dec 22, 2006 · Event occurred Oct 20, 2006
Report 2921578-2006-00005 · MDR key 800552
Device
Generic name
Operating Room Table
Manufacturer
Orthopedic Systems, Inc.Model number
5803Catalog number
5803
Lot number
*
Product problems
- Perivalvular Leak
- Replace
- Table, tilting
Patient
37 YR
- No Consequences Or Impact To Patient
Narrative
Additional Manufacturer Narrative
DEVICE WAS REPAIRED. USER ALLOWED MAINTENANCE OF TABLE TO GO BEYOND SAFE USE. REPAIR ORDER CREATED, ITEMS FOR REPAIR IDENTIFIED REPLACEMENT ACTUATOR AND KNOB REPLACEMENT ASSEMBLY. TABLE IS CURRENTLY IN USE.
Description of Event or Problem
THE PT WAS UNDERGOING HIP ARTHROPLASTY, AND AFTER THE DISTRACTION OF THE RIGHT HIP JOINT WAS APPLIED, AN ATTEMPT WAS MADE TO TILT THE TABLE FOR BETTER ACCESS. THE ANESTHESIOLOGITS WAS UNFAMILIAR WITH THE BED AND DID NOT KNOW IT WOULD NOT ROTATE 180 DEGREES. SHE WAS UNABLE TO GET THE BED TO TILT USING THE HAND CONTROL AND SEEING THE "LOCK/UNLOCK" LEVER ON THE BED, SHE UNLOCKED IT THINKING THAT WAS WHY THE BED WOULD NOT TILT. THE TABLETOP ROTATED AND THE PT WAS LEFT DANGLING BY THE TWO SAFETY STRAPS (ACROSS CHEST AND UNAFFECTED LEG). THE HEALTHCARE TEAM REACTED SWIFTYLY AND WAS ABLE TO MAINTAIN THE SECURITY OF HIS AIRWAY AND REORIENT THE BED. HE WAS MOVED TO ANOTHER BED.
Remedial action
- Repair