MAUDE Adverse Event Report: DRAEGER MEDICAL SYSTEMS, INC BILILUX PHOTOTHERAPY LIGHT; LED PHOTOTHERAPY SYSTEM - JAUNDICE MANAGEMENT SYSTEMS

Catalog Number	MU20100
Medical Device Problem Codes	Detachment of Device or Device Component (2907); Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/23/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The investigation has just started; results will be provided in a follow-up report.H3 other text : ongoing.
Event or Problem Description
It was reported that the photo therapy lamp was dislodged from its stand and fell into the patient compartment.It was confirmed by the user that the reported incident did not result in any health consequences for the patient.
Additional Manufacturer Narrative
A complaint was received involving a bililux light disconnecting from a bililux spring arm into a patient's cot.No adverse patient impact was reported.Additional information was requested.It was confirmed that the device was assembled using a right-angled power cord, rather than the draeger power cord provided (type g, part number 1851713, cable great britian,3m,10a).No repairs were performed on the light or the spring arm as a result of the event; the devices were put back into service.It is unknown if the user performed the functional check prior to use, if the user heard an audible 'click' when attaching the lamp to the spring arm, or if the user confirmed that the light was locked in place prior to use.To resolve the issue, the hospital staff were reminded they must ensure the light is correctly installed onto the spring arm and to listen for an audible click.The right-angled power cord was removed from device and replaced with a straight lead.Based on the results of the investigation, root cause was identified as user error.No further issues have been reported.Per the instructions for use, when attaching the bililux light to the spring arm, "insert the quick-connect plug on the phototherapy light into the arm socket until it audibly clicks into place." this information was shared with the customer.Per the instructions for use, "a malfunctioning phototherapy system may not provide correct therapy.To ensure proper functionality, perform the functional check procedure before the device is first placed into service, after it has been turned off, and after cleaning or service procedures.Do not use the device if a malfunction was detected during the functional check procedure.Do not use the device if any controls are not functional or if the device does not pass the functional check procedure successfully." the functional checklist was shared with the customer.
Event or Problem Description
It was reported that the photo therapy lamp was dislodged from its stand and fell into the patient compartment.It was confirmed by the user that the reported incident did not result in any health consequences for the patient.

• Brand Name: BILILUX PHOTOTHERAPY LIGHT
• Common Device Name: LED PHOTOTHERAPY SYSTEM - JAUNDICE MANAGEMENT SYSTEMS
• Manufacturer (Section D): DRAEGER MEDICAL SYSTEMS, INC; 3135 quarry road; telford PA
• Manufacturer (Section G): DRAEGER MEDICAL SYSTEMS, INC.; 3135 quarry road; telford PA
• Manufacturer Contact: 3135 quarry road; telford, PA ; 2156602400
• MDR Report Key: 18552796
• Report Number: 1220063-2024-00009
• Device Sequence Number: 12687661
• Product Code: LBI
• UDI-Device Identifier: 04049098094900
• UDI-Public: (01)04049098094900(11)190320(21)1097771020(93)MU20100-10
• Combination Product (Y/N): N
• PMA/510(K) Number: K954611
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: User Facility,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 05/08/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: MU20100
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 01/08/2024
• Supplement Date Received by Manufacturer: 04/02/2024
• Initial Report FDA Received Date: 01/22/2024
• Supplement Report FDA Received Date: 05/08/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 03/20/2019
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown