MAUDE Adverse Event Report: DRAEGER MEDICAL SYSTEMS, INC BILILUX PHOTOTHERAPY LIGHT; OVERHEAD INFANT PHOTOTHERAPY UNIT

Catalog Number	MU20100
Medical Device Problem Code	Device Tipped Over (2589)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/15/2024
Type of Reportable Event	Malfunction
Event or Problem Description
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.
Event or Problem Description
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.

• Brand Name: BILILUX PHOTOTHERAPY LIGHT
• Common Device Name: OVERHEAD INFANT PHOTOTHERAPY UNIT
• 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: 18866231
• Report Number: 1220063-2024-00029
• Device Sequence Number: 8240052
• Product Code: LBI
• UDI-Device Identifier: 04049098094900
• UDI-Public: (01)04049098094900(11)210914(93)MU20100-15
• Combination Product (Y/N): N
• PMA/510(K) Number: K172656
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 05/03/2024

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): Initial
• Initial Date Received by Manufacturer: 02/26/2024
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 03/08/2024
• Supplement Report FDA Received Date: 05/03/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 03/09/2021
• 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
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown