MAUDE Adverse Event Report: BAXTER HEALTHCARE CORPORATION TRULIGHT; LAMP, OPERATING-ROOM

Model Number	4038310
Medical Device Problem Code	Device Fell (4014)
Health Effect - Clinical Codes	Head Injury (1879); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/23/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported a trulight fell and injured a healthcare professional.During a procedure, the trulight ¿became disengaged¿ and ¿fell on the anesthesiologist¿s head.¿ the event caused an unspecified injury to the physician.It was later clarified that the anesthesiologist was hit on their head by the monitor dropping back down after being pushed up.Details of the reported injury and whether any medical intervention were required were not further specified.An inspection performed by a third-party technician noted that the device arm was dropping due to plexiglass screen protectors added by the facility¿s biomed.These screens added extra weight to the arms, which caused the monitor to slowly drift.The field service technician set the max tension on the spring arms to ensure that the spring arms do not drift.Additionally, the event was likely due to a user error/misuse of the device, as the customer did not inform baxter nor the third-party technician of the device modification performed that caused the monitor to drift.No further information was available at the time of this report.
Additional Manufacturer Narrative
Should additional relevant information become available, a supplemental report will be submitted.
Additional Manufacturer Narrative
Additional information: d9, h6 and h11.H11: the device was evaluated by a qualified on-site technician.During evaluation, the technician found the customer added monitor covers which caused the arms to be loaded beyond the rated weight capacity.The customer ¿insisted¿ on retaining the monitor covers.A service history review was performed and revealed that the device has no previous service events; therefore, servicing did not cause or contribute to the reported event.The reported condition was verified.The cause of the condition was due to the weight of the monitor covers applied by the customer.Should additional relevant information become available, a supplemental report will be submitted.
Additional Manufacturer Narrative
Additional information: h11: the device was evaluated by a qualified on-site technician.Additional information from the technician found the spring arm wasn¿t adjusted correctly to the additional attached weight of the plexiglass cover.Once the monitor was installed, the biomed added a plexiglass cover on the screen post adjustment of the tension.Tension on this spring arm needed to be tightened to ensure that it doesn¿t drift downwards over time.The reported condition was verified.The cause of the condition was due to the plexiglass screen protectors installed by biomed and the fact that the springarm wasn't adjusted to accommodate the additional weight.The plexiglass protectors add an extra pound or two, which causes the monitor to slowly drift down.The protectors are intended to prevent damages caused by staff interactions.The screen protectors can be added on the monitor as long as not exceeding the maximum load of the spring arm capacity.A nonconformance has been opened to address this issue.Should additional relevant information become available, a supplemental report will be submitted.
Additional Manufacturer Narrative
Additional information: b5: upon follow-up with the customer, the anesthesiologist sustained a hematoma and a bump on their head; however, no medical intervention was required.Additionally, the anesthesiologist was able to carry out their duties on that day and did not require any time off work nor additional exams.Therefore, the anesthesiologist did not sustain permanent impairment of a body function or permanent damage to a body structure and did not require medical or surgical intervention to preclude permanent impairment of a body function or permanent damage to a body structure, which concludes that no serious injury occurred.Should additional relevant information become available, a supplemental report will be submitted.

• Brand Name: TRULIGHT
• Common Device Name: LAMP, OPERATING-ROOM
• Manufacturer (Section D): BAXTER HEALTHCARE CORPORATION; deerfield IL
• Manufacturer (Section G): HILL-ROM COMPANY INC.; 4279 u crosspoint drive; ladson SC 29456
• Manufacturer Contact: 25212 w. illinois route 120; round lake, IL 60073 ; 2242702068
• MDR Report Key: 22293424
• Report Number: 3003184737-2025-00002
• Device Sequence Number: 8310320
• Product Code: FQP
• UDI-Device Identifier: 00887761995901
• UDI-Public: (01)00887761995901
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: NA
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 11/18/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: 4038310
• Device Catalogue Number: 1532467
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/23/2025
• Supplement Date Received by Manufacturer: 06/25/2025; 08/19/2025; 10/20/2025
• Initial Report FDA Received Date: 06/19/2025
• Supplement Report FDA Received Date: 07/17/2025; 09/17/2025; 11/18/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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
• Concomitant Medical Products and Therapy/Usage Dates: NI.
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown