BILILUX PHOTOTHERAPY LIGHT

Description of Event or Problem

A CUSTOMER REPORTED THAT A BILILUX SPRING ARM SLOWLY COLLAPSED ONTO PEDIATRIC PATIENT. NO DEATH WAS REPORTED, AND THE CUSTOMER CONFIRMED THAT THERE WAS NO PATIENT INJURY. IT WAS DETERMINED THAT THE SWING ARM BOLT HAD COME LOOSE OVER TIME AND REQUIRED TIGHTENING.

Additional Manufacturer Narrative

THE INVESTIGATION WAS STARTED; RESULTS WILL BE PROVIDED IN A FOLLOW UP-REPORT.

Description of Event or Problem

A CUSTOMER REPORTED THAT A BILILUX SPRING ARM SLOWLY COLLAPSED ONTO PEDIATRIC PATIENT. NO DEATH WAS REPORTED, AND THE CUSTOMER CONFIRMED THAT THERE WAS NO PATIENT INJURY. IT WAS DETERMINED THAT THE SWING ARM BOLT HAD COME LOOSE OVER TIME AND REQUIRED TIGHTENING.

Additional Manufacturer Narrative

A COMPLAINT WAS RECEIVED INVOLVING A BILILUX THAT SLOWLY DRIFTED DOWNWARD ONTO A PATIENT. IT WAS REPORTED THAT THE SWING ARM DID NOT HOLD IN REQUIRED POSITION AFTER BEING SET. IN THE GENERAL CUSTOMER REPORT ATTACHED TO THIS RECORD, THERE WAS NO REPORT OF AN ADVERSE PATIENT IMPACT. IT WAS REPORTED THAT THE SWING ARM NUT AND BOLT HAD COME LOOSE OVER TIME AND REQUIRED TIGHTENING. SEVERAL ATTEMPTS WERE MADE TO OBTAIN FURTHER INFORMATION INCLUDING WHO REPAIRED THE DEVICE TO RESOLVE THE ISSUE, THE HISTORY OF PREVENTATIVE MAINTENANCE AND IF THE FUNCTIONAL CHECKOUT WAS PERFORMED PRIOR TO USE AS OUTLINED IN THE INSTRUCTIONS FOR USE (IFU). NO FURTHER INFORMATION WAS MADE AVAILABLE THEREFORE, A ROOT CAUSE COULD NOT BE DETERMINED.