MAUDE Adverse Event Report: BAXTER MEDICAL SYSTEMS GMBH + CO. KG ILED 7 CEILING TRIO; SURGICAL LIGHT

Model Number 4068310

Device Problem Excessive Heating (4030)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 02/28/2024

Event Type  malfunction  

Manufacturer Narrative

It was reported that when the facility manager experimented the iled 7 ceiling trio lights on himself he felt warm under the ot scrub and observed redness after 20 mins.It was noted that the 3 lights were being used at the same time, and set at 100% intensity and 5000k colour temperature.No medical intervention was required.During follow-up with the customer, it was noted that the customer was unaware of the remaining risk associated with the overlapping of 2 or more lights.The iled 7 device is intended for use in a patient environment and is used to illuminate an examination and surgical area on the patient with high lighting intensity in a hospital or medical practice.The iled light features settings for lighting intensity, color, temperature, field of illumination, size, shadow management and synchronization.The light can be operated using an operating element on the lamp head, on the control/wall control panel, or via an optional sterile hand grip.The device user manual states the working range is at a distance between 70 and 150cm (2.3 and 5 feet) from the wound area.The iled 7 surgical light was designed according to iec 60601-2-41 2009/a1:2013 and meets these requirements.The iec also indicates that overlapping of more than one light field (luminaires) can exceed the irradiance of 1000 w/m².Therefore, information shall be given with the instructions for use (ifu) that there is a risk of too much heat in the operating field.The iled 7 ifu includes a warning for this risk as well as for other conditions where it is possible to increase the irradiance.The 1000 w/m² are the limits for potential undesirable temperature rise in the operating field per the iec.The iled 7 produces 623 w/m² for the single light head.In case of overlapping with high intensity the 1000 w/m² may be exceeded.Warnings include overlapping fields of illumination of several lamp heads with high lighting intensities can cause tissue damage.The ifu states overlapping field of illumination of several lamp heads with high lighting intensities can cause tissue damage.With early onset of tissue dehydration, separate the overlapping fields of illumination of multiple lamp heads and reduce the lighting intensity of the lamp heads.Additionally, the ifu states according to the laws of physics, visible light also produces heat in the operating area.If the fields of illumination of more than one lamp head overlap, high illumination levels are created, which may lead to tissue dehydration especially with longer periods of exposure and reduced blood circulation, to tissue damage.In case of reduced blood circulation or any symptoms of tissue dehydration, the lighting intensity must be reduced.The headlights involved in this event were inspected and found within specification, no malfunction was identified.In this event, the reported injury (skin redness) did not result in harm to the staff member, who did not require medical or surgical intervention to preclude permanent impairment of a body function or permanent damage to a body structure, which concludes no serious injury occurred.Additionally, no device malfunction was identified upon inspection.However, if a similar event were to recur (incorrect overhead light handling/usage), it would likely cause or contribute to serious injury or death.

Event Description

It was reported that when the facility manager experimented the iled 7 ceiling trio lights on himself he felt warm under the ot scrub and observed redness after 20 mins.It was noted that the 3 lights were being used at the same time, and set at 100% intensity and 5000k colour temperature.No medical intervention was required.During follow-up with the customer, it was noted that the customer was unaware of the remaining risk associated with the overlapping of 2 or more lights.This report was filed in our complaint handling system as complaint #(b)(4).

• Brand Name: ILED 7 CEILING TRIO
• Type of Device: SURGICAL LIGHT
• Manufacturer (Section D): BAXTER MEDICAL SYSTEMS GMBH + CO. KG; carl-zeiss-strasse 7-9; saalfeld thuringen 07318 ; GM 07318
• Manufacturer Contact: frances coote ; carl zeiss strasse 7-9; saalfeld thuringen 07318 ; GM 07318
• MDR Report Key: 19051040
• MDR Text Key: 340456718
• Report Number: 3007143268-2024-00013
• Device Sequence Number: 1
• Product Code: FSY
• UDI-Device Identifier: 00887761995840
• UDI-Public: 887761995840
• Combination Product (y/n): N
• Reporter Country Code: SN
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 04/05/2024

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
• Device Model Number: 4068310
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 03/08/2024
• Initial Date FDA Received: 04/05/2024
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1