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

Catalog Number	MU20100
Medical Device Problem Code	Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/30/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the bililux detached from the connection to the articulating arm.According to the clinician it did fall onto the infant, and that the infant was not harmed.No adverse patient impact or death reported.
Additional Manufacturer Narrative
A complaint was received involving a bililux light disconnecting from the spring arm into a patient's cot.No adverse patient impact was reported.According to service report (b)(4) the field service engineer (fse) observed that the connection was disassembled, and he then replaced the entire swing arm to repair.The fse later stated in his (b)(6) 2024 email response that he did not disassembly the joint assembly and was unsure if this was done by the customer or biomed.The swing arm in question, along with all of the connection parts were sent to telford for analysis.In his investigation report the quality engineer explained that the press fit joint of the swing arm provides significant engagement and friction when inserted into the joint assembly.This is inherent in the design of the joint and at the time of assembly washers and a circlip are also inserted to lock the press fit joint into place.Additionally, there is a screw and a nut installed on the joint assembly to further tighten the assembly around the press fit joint.If this screw and nut were not maintained in a tight position and the circlip was not in place, the press fitting could be pulled out of the assembly, but only with significant force.The quality engineer then tested the tightness of the joint based on the engagement of the press fit joint only, without using the screw and nut or the circlip and washers.A bililux device was attached to this spring arm without the circlip, washers, nut and screw and allowed to hang for 1 hour.After this timeframe, the bililux was still in place and had not slipped out of the joint assembly to any degree nor fallen to the floor.At this time, the quality engineer had to pull with a significant amount of force in order to get the press fitting joint to disengage from the assembly.In the quality engineer's assessment, it is possible that the circlip was not installed at the time of assembly however, even if this part was not engaged, the other two design elements of joint assembly are sufficient to hold the press joint and therefore, the device in place.There are several sections in the instructions for use (ifu) stating periodic checks of the swing arm are required as a part of the bililux functional check prior to be placed in use with a patient.This functional check includes conforming that the device moves smoothly and maintains position within the spring arm, that fasteners are checked, and that there must be an audible click when the light itself is inserted into the quick-connect plug of the swing arm.Furthermore, safety checks as well as maintenance of the swing arm as outlined in the ifu should be conducted yearly.This swing arm was confirmed to be the original purchased with this bililux in (b)(6) 2022, making the arm close to 2 years old at the time of the event (30jun24).Maintenance of this device and swing arm were unable to be confirmed as multiple attempts to obtain this information were unsuccessful and sap had no install or service reports listed for this device.In addition to the maintenance of the swing arm, other information was also requested including if the user was moving the device at the time of the occurrence or how long the device was being used with a patient before the event occurred.This information was not made available therefore, an exact root cause cannot be determined.With the replacement of a new swing arm, no further issues have been reported.Additional information per the instructions for use, regarding attaching the bililux light to the spring arm: per the instructions for use, "risk if service is not performed regularly.Wear and material fatigue of the components may lead to device failure and malfunctions." perform service at the specified intervals.Personal injury and property damage may occur if service is not performed properly.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.
Event or Problem Description
It was reported that the bililux detached from the connection to the articulating arm.According to the clinician it did fall onto the infant, and that the infant was not harmed.No adverse patient impact or death reported.

• 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 18969
• Manufacturer Contact: 3135 quarry road; telford, PA 18969 ; 9784828529
• MDR Report Key: 19861241
• Report Number: 2510954-2024-00036
• Device Sequence Number: 7514466
• Product Code: LBI
• UDI-Device Identifier: 04049098094900
• UDI-Public: (01)04049098094900(11)220427(93)MU20100-17
• Combination Product (Y/N): N
• PMA/510(K) Number: K954611
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,User Facility,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 09/23/2024

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?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/22/2024
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 07/01/2024
• Supplement Date Received by Manufacturer: 07/01/2024
• Initial Report FDA Received Date: 07/30/2024
• Supplement Report FDA Received Date: 09/23/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/27/2022
• 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: Unknown
• Patient Sequence Number: 1
• Patient Sex: Unknown