• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

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

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

BAXTER MEDICAL SYSTEMS GMBH + CO. KG ILED 7 CEILING DUO; SURGICAL LIGHT Back to Search Results
Model Number 4068210
Device Problem Appropriate Term/Code Not Available (3191)
Patient Problem Laceration(s) (1946)
Event Date 01/26/2023
Event Type  Injury  
Manufacturer Narrative
The inspection of the iled 7 lights was performed by a hillrom/baxter technician using a light meter to measure light intensity and temperature.The inspection confirmed that all lights were functioning as designed and noted that all were within the 160,000 lux limit of intensity.In this event, the customer alleged the intensity level of the surgical lights was too high and the patient sustained a laceration that required medical intervention (suture and dermabond) to preclude permanent impairment of a body function or permanent damage to a body structure, concluding a serious injury occurred in this case.The inspection ruled out a device malfunction; however, the customer acknowledged overlapping of light fields which likely caused or contributed to this reported event.Prevention of this type of event is outlined as described in the ifu.Based on this no further action is required.
 
Event Description
The customer reported that at the end of the procedure when drapes were taken down it was noted that the patient had an approximately 1" laceration on the right anterior lower leg.The laceration was cleaned, sutured and dermabond was applied.The laceration was covered with tegaderm, and the patient was taken to recovery.The patient¿s laceration healed.The customer alleged the intensity level of the surgical lights was too high and causing the injury.This report was filed in our complaint handling system as complaint # (b)(4).
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand Name
ILED 7 CEILING DUO
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 Key17115768
MDR Text Key317038733
Report Number3007143268-2023-00020
Device Sequence Number1
Product Code FSY
UDI-Device Identifier00887761995857
UDI-Public887761995857
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type User Facility
Reporter Occupation Other
Type of Report Initial
Report Date 06/13/2023
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? No
Device Model Number4068210
Was Device Available for Evaluation? Yes
Was the Report Sent to FDA? No
Initial Date Manufacturer Received 05/15/2023
Initial Date FDA Received06/13/2023
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 Number1
Patient Outcome(s) Required Intervention;
Patient Age73 YR
Patient SexFemale
-
-