inforMED
InjuryBWN

SKYTRON 6001

Received Mar 13, 2008 · Event occurred Nov 17, 2004

Report MW5005868 · MDR key 1013899

Device

Generic name

Operating Room Table- Hydraulic

Manufacturer

Skytron

Model number

6001

Product problems

  • Mechanical Problem
  • Repair
  • Self-Activation or Keying
  • Use of Device Problem
  • Device Issue

Patient

Not reported

  • Fall
  • Spinal Column Injury
  • Injury
  • Surgical procedure
  • Hospitalization required

Narrative

Description of Event or Problem

OPERATING ROOM TABLE MALFUNCTION RESULTING IN PT INJURY REQUIRING HOSPITALIZATION AND LEGAL CLAIM AGAINST FACILITY. TABLE EVALUATED BY CONTRACTED THIRD PARTY REPAIR. NOTES INDICATED USER ERROR. HAND CONTROL REPLACED. TABLE RETURNED TO SERVICE PER CONTRACTOR'S EVALUATION. SEVERAL CALLS MADE TO THIRD PARTY CONTRACTOR FOR COMPLAINTS OF TABLE INSTABILITY. NO FAULTS OR TABLE ERRORS FOUND PER FIELD SERVICE REPORTS. TABLE RETURNED TO SERVICE EACH TIME WITH NO ERRORS FOUND PER FIELD SERVICE REPORTS. ON 11/15/2006 TABLE MALFUNCTIONED WITH FAILURE OF THE HYDRAULIC SYSTEM WHILE A 340+ POUND PT WAS ANESTHETIZED ON THAT TABLE. FAILURE OF THE HYDRAULICS CAUSED THE PT TO IMMEDIATELY BEGIN HEADING HEAD FIRST TO THE FLOOR. I CAUGHT THE PT AND SUSTAINED A PERSONAL CERVICAL NECK INJURY WHICH REQUIRED SURGICAL REPAIR. TABLE EVALUATED BY THIRD PARTY CONTRACTORS. FIELD SERVICE REPORT INDICATED USER ERROR. TABLE RETURNED TO SERVICE PER FIELD SERVICE REPORT. IN 2007: THE SAME OPERATING ROOM TABLE MALFUNCTIONED AND LOCKED ITSELF IN THE FULL TABLE UP, TABLE TILT AND LEG DOWN POSITION OVERNIGHT AND ON ITS OWN. THIRD PARTY CONTRACTOR NOTIFIED. PER FIELD SERVICE REPORT RECOMMENDATION: REMOVE TABLE FROM SERVICE DUE TO PERMANENT MALFUNCTION AND NON-REPAIRABLE STATE FOR THE SAFETY OF FUTURE PTS. IN THEIR OWN OPINION, THE TABLE DID IN FACT HAVE UNDERLYING ISSUES ALL ALONG YET BECAUSE OF THE TRANSIENT NATURE OF THE PROBLEMS, IT WAS DIFFICULT FOR THEM TO DIAGNOSE.