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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BAXTER MEDICAL SYSTEMS GMBH + CO. KG ILED 7 CEILING TRIO; SURGICAL LIGHT
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BAXTER MEDICAL SYSTEMS GMBH + CO. KG ILED 7 CEILING TRIO; SURGICAL LIGHT Back to Search Results
Model Number 4068310
Device Problem Insufficient Information (3190)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 02/28/2024
Event Type  malfunction  
Event Description
It was reported that during an ot case simulation with the iled 7 ceiling trio lights, one of the nurse was on the operating table.The light was set at 100% intensity, colour temperature 5000k, shining on the nursed knee, who was wearing ot scrub.After approximately 6 to 10 minutes, the nurse felt discomfort on the knee, and when they rolled up the scrub, they found there was redness on the knee.No medical intervention was required.This report was filed in our complaint handling system as complaint #(b)(4).
 
Manufacturer Narrative
Inspection of the device is pending.Further investigation should confirm the root cause.Investigation results will be provided within a final report if new information will become available.
 
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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 Key19050492
MDR Text Key339478404
Report Number3007143268-2024-00012
Device Sequence Number1
Product Code FSY
UDI-Device Identifier00887761995840
UDI-Public887761995840
Combination Product (y/n)N
Reporter Country CodeSN
Number of Events Reported1
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
Date FDA Received04/05/2024
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Model Number4068310
Was Device Available for Evaluation? Yes
Was the Report Sent to FDA? No
Date Manufacturer Received03/08/2024
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse
Patient Sequence Number1
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