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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MAQUET SAS LUCEA 50 MOBILE; LIGHT, SURGICAL, FLOOR STANDING
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MAQUET SAS LUCEA 50 MOBILE; LIGHT, SURGICAL, FLOOR STANDING Back to Search Results
Model Number ARDLCA309004A
Device Problem Detachment of Device or Device Component (2907)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Type  malfunction  
Event Description
On 15th november, 2023 getinge became aware of an issue with one of surgical lights ¿ lucea 50 mobile.Based on photographic evidence the cap was missing from the spring arm.We decided to report the issue in abundance of caution as any part or particles falling off into sterile field or during procedure may cause contamination.
 
Manufacturer Narrative
Additional information will be provided following the conclusion of the investigation.H3 other text : device not returned to manufacturer.
 
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Brand Name
LUCEA 50 MOBILE
Type of Device
LIGHT, SURGICAL, FLOOR STANDING
Manufacturer (Section D)
MAQUET SAS
parc de limere
avenue de la pomme de pin
ardon
Manufacturer (Section G)
MAQUET SAS
parc de limere
avenue de la pomme de pin
ardon
Manufacturer Contact
pascal jay
parc de limere
avenue de la pomme de pin
ardon 
MDR Report Key18197993
MDR Text Key328899883
Report Number9710055-2023-00908
Device Sequence Number1
Product Code FSS
Combination Product (y/n)N
Reporter Country CodeBR
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Foreign,User Facility,Company Representative
Reporter Occupation Other
Type of Report Initial
Report Date 11/21/2023
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received11/23/2023
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Model NumberARDLCA309004A
Device Catalogue NumberARDLCA309004A
Was Device Available for Evaluation? Yes
Date Manufacturer Received11/15/2023
Was Device Evaluated by Manufacturer? No
Date Device Manufactured04/06/2021
Is the Device Single Use? No
Type of Device Usage Reuse
Patient Sequence Number1
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