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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

Model number

5803

Catalog 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