BILILUX PHOTOTHERAPY LIGHT
Received Aug 13, 2025 · Event occurred Aug 5, 2025
Report 2510954-2025-00005 · MDR key 22797546
Device
Generic name
Led Phototherapy System - Jaundice Management Systems
Manufacturer
Draeger Medical Systems, IncModel number
N/ACatalog number
MU20100
Lot number
N/A
Product problems
- Unstable
- Unstable
Patient
NA · Unknown
- Bruise/Contusion
- Bruise/Contusion
Narrative
Additional Manufacturer Narrative
A CUSTOMER REPORTED THAT THE BILILUX SPRING ARM SPRUNG UP AND HIT THE OPERATOR'S FACE. ADDITIONAL INFORMATION WAS REQUESTED REGARDING THE OPERATOR'S CONDITION; THE OPERATOR HAD SOME BRUISING ON THE FACE BUT NOT DID NOT REQUIRE MEDICAL TREATMENT. THE FUNCTIONAL CHECKOUT PROCEDURE WAS PERFORMED, AND THE SPRING ARM DID NOT STAY IN POSITION AND WAS REMOVED FROM SERVICE. THE AFFECTED SPRING ARM WAS REQUESTED FOR INVESTIGATION AND WAS EVALUATED BY DRAEGER. THE REPORTED SYMPTOM WAS CONFIRMED. THE JOINT ON THE SPRING ARM WAS INSPECTED, AND IT WAS FOUND THAT THE CENTER JOINT NUT WAS LOOSE AND NEEDED TO BE TIGHTEN. AFTER TIGHTENING THE NUT ON THE CENTER JOINT, THE SPRING ARM FUNCTIONED AS INTENDED. ROOT CAUSE WAS IDENTIFIED AS A LACK OF PREVENTIVE MAINTENANCE. THE BILILUX INSTRUCTIONS FOR USE PREVENTIVE MAINTENANCE INTERVALS REQUIRES THE USER TO TIGHTEN THE SPRING ARM JOINTS ONCE A YEAR OR WHEN THE SPRING ARM NO LONGER MAINTAINS POSITION. THE BILILUX INSTRUCTIONS FOR USE FUNCTIONAL CHECKOUT PROCEDURE AND PREVENTIVE MAINTENANCE INTERVALS WERE SHARED WITH THE CUSTOMER. NO FURTHER ISSUES HAVE BEEN REPORTED. THE PRODUCT RISK MANAGEMENT REPORT WAS REVIEWED, AND NO NEW RISKS WERE IDENTIFIED. THERE WAS NO DEVICE MALFUNCTION. THEREFORE, NO FOLLOW UP ACTION IS REQUIRED.
Description of Event or Problem
IT WAS REPORTED THAT THE BILILUX SPRING ARM SPRUNG OUT AND HIT THE NURSE IN THE FACE WHEN THEY REMOVED THE BILILUX FROM THE QUICK COUPLING MECHANISM. THE NURSE DEVELOPED A BRUISE ON THEIR FACE. AN X-RAY OF THE INJURY WAS PERFORMED AND CONFIRMED THERE WAS NO FRACTURE. THE TENSION IN THE SPRING ARM WAS CONFIRMED TO BE FAULTY AND WAS UNABLE TO STAY IN PLACE. THE SPRING ARM, BILILUX, AND TROLLEY WERE REMOVED FROM SERVICE.
Additional Manufacturer Narrative
THE INVESTIGATION HAS STARTED. A FOLLOW UP REPORT WILL BE SUBMITTED UPON COMPLETION.
Description of Event or Problem
IT WAS REPORTED THAT THE BILILUX SPRING ARM SPRUNG OUT AND HIT THE NURSE IN THE FACE WHEN THEY REMOVED THE BILILUX FROM THE QUICK COUPLING MECHANISM. THE NURSE DEVELOPED A BRUISE ON THEIR FACE. AN X-RAY OF THE INJURY WAS PERFORMED AND CONFIRMED THERE WAS NO FRACTURE. THE TENSION IN THE SPRING ARM WAS CONFIRMED TO BE FAULTY AND WAS UNABLE TO STAY IN PLACE. THE SPRING ARM, BILILUX, AND TROLLEY WERE REMOVED FROM SERVICE.