BILILUX PHOTOTHERAPY LIGHT
Received Mar 10, 2025 · Event occurred Feb 7, 2025
Report 2510954-2025-00001 · MDR key 21560832
Device
Generic name
Led Phototherapy System - Jaundice Management Systems
Manufacturer
Draeger Medical Systems, Inc.Catalog number
MU20100
Product problems
- Device Dislodged or Dislocated
- Device Fell
- Device Dislodged or Dislocated
- Device Fell
Patient
NA · Unknown
- No Clinical Signs, Symptoms or Conditions
- No Clinical Signs, Symptoms or Conditions
Narrative
Additional Manufacturer Narrative
IT COULD NOT BE CONFIRMED IF THE CUSTOMER PERFORMED THE OPERATIONAL CHECKOUT PRIOR TO PUTTING THE BILILUX INTO USE. REVIEW OF THE PHOTOS PROVIDED SHOW THE SPRING ARM ADAPTER WAS IN GOOD CONDITION AND THE SCREW HOLDING THE SPRING ARM ADAPTER TO THE SPRING ARM CAME LOOSE. THEREFORE, ROOT CAUSE OF THE BILILUX FALLING TOWARD THE PATIENT WAS DUE TO A LACK OF MAINTENANCE OF THE BILILUX SPRING ARM. AS A PREVENTIVE MEASURE, DRAEGER REPLACED THE SPRING ARM AND EMPHASIZED TO THE CUSTOMER THE NEED FOR REGULAR MAINTENANCE OF SPRING ARM. NO FURTHER ISSUES HAVE BEEN REPORTED.
Description of Event or Problem
IT WAS REPORTED AS TIME PASSES ON THE BILILUX, THE PART HOLDING ARM SOCKET SLOWLY LOOSEN, THIS RESULTS IN DROPPING THE BILILUX HEAD DOWN TOWARDS THE PATIENT. THE DEVICE USED WITHOUT THE HOOD CLOSED. THERE WAS NO ADVERSE PATIENT IMPACT REPORTED.
Additional Manufacturer Narrative
THE INVESTIGATION HAS STARTED. A FOLLOW UP REPORT WILL BE SUBMITTED UPON COMPLETION.
Description of Event or Problem
IT WAS REPORTED AS TIME PASSES ON THE BILILUX, THE PART HOLDING ARM SOCKET SLOWLY LOOSEN, THIS RESULTS IN DROPPING THE BILILUX HEAD DOWN TOWARDS THE PATIENT. THE DEVICE USED WITHOUT THE HOOD CLOSED. THERE WAS NO ADVERSE PATIENT IMPACT REPORTED.