FDA Adverse Event Malfunction Summary report: N

JACKSON TABLE

MDR report key: 1567142 · Received December 22, 2009

Report

Report Number
1567142
Event Type
Malfunction
Date Received
December 22, 2009
Date of Event
November 20, 2009
Report Date
December 22, 2009
Manufacturer
MIZUHO ORTHOPEDIC SYSTEMS, INC.
Product Code
FQO
Product Problem
Yes
Report Source
User Facility report
Reporter Location
AZ, US
Reporter Occupation
RISK MANAGER

Narratives

Description of Event or Problem · 1

PATIENT WAS ON A JACKSON TABLE IN PRONE POSITION WITH EPIDURAL NEEDLES AND LEADS IN PLACE IN LOWER BACK. ALL THREE BLUE LOCK INDICATOR LIGHTS WERE ON. SURGEON NEEDED PATIENT TO BE REPOSITIONED AND ASKED FOR HER TO BE TILTED LATERALLY TO THE LEFT. ANESTHESIA RESIDENT STARTED TO TILT TABLE USING THE HAND CONTROL WHEN SUDDENLY TABLE TILTED TO ABOUT 80 DEGREES. PATIENT'S TORSO FELL OFF THE TABLE, THE SURGEON TRIED TO BREAK THE FALL BUT PATIENT LANDED ON THE FLOOR ONTO THEIR LEFT SHOULDER. SAFETY STRAPS AROUND THE THIGHS KEPT THE PATIENT'S LEGS ON THE TABLE, PREVENTING THE PATIENT FROM COMPLETELY FALLING ONTO THE FLOOR.MANUFACTURER RESPONSE (AS PER REPORTER) FOR JACKSON TABLE, JACKSON TABLEMIZUHO ORTHOPEDIC SYSTEMS, INC. SENT A SERVICE TECHNICIAN WHO IS SUBCONTRACTED WITH REDMED. THE TECHNICIAN WAS NOT ABLE TO INDENTIFY OR RECREATE THE MALFUNCTION, STATING THAT THE BED WAS WORKING THE WAY IT WAS SUPPOSE TOO. THE TABLE PASSED HIS PREVENTIVE MAINTENANCE CHECK LIST. SIX DAYS LATER, THE SAME TECH CAME TO REPLACE THE ROTATION SAFETY LOCK SWITCH THAT OPERATED THE FOOT LOCK MECHANISM (HE STATED THAT HAS NOTHING TO DO WITH THE EVENT OF THE TABLE) AND A RUBBER PAD FOR THE BASE. A FEW WEEKS LATER, MIZUHO ORTHOPEDIC SYSTEMS, INC. SENT THEIR TECHNICIAN AND HE WAS ABLE TO FIND THE MALFUNCTION, RE-CREATE IT AND MAKE THE REPAIR. HE FOUND THAT THE TORQUE NEEDED TO BE RESET AND THAT WAS WHAT WAS CAUSING THE LOCKING MECHANISM TO FAIL. BECAUSE THE JACKSON TABLE IS USED SO MUCH AT OUR FACILITY, IT LOST THE PRESET TORQUE SETTING. THIS INFORMATION WAS NOT CONVEYED TO OUR BME DEPARTMENT AFTER THE PURCHASE OF JACKSON TABLE; NOW CHECKING THE TORQUE WILL BE PART OF THE PREVENTIVE MAINTENANCE CHECKLIST.

Devices

Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
1 JACKSON TABLE TABLE, OPERATING FQO MIZUHO ORTHOPEDIC SYSTEMS, INC. 5803 *

Patients

Seq Age Sex Outcome Treatment
1 37 YR OTHER