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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MAQUET SAS LUCEA 50/100 LAMP, SURGICAL

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MAQUET SAS LUCEA 50/100 LAMP, SURGICAL Back to Search Results
Catalog Number ARDLCA219001A
Device Problem Detachment of Device or Device Component (2907)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Type  malfunction  
Manufacturer Narrative
Additional information will be provided following the conclusion of the investigation. Device not returned to manufacturer.
 
Event Description
On (b)(6) 2021 getinge became aware of an issue with surgical light - lucea 100. The upper and lower cover were cracked resulting in falling particles. There was no injury reported, however, we decided to report the issue in abundance of caution, as parts or particles falling off into sterile field or during procedure may cause contamination or injury.
 
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Brand NameLUCEA 50/100
Type of DeviceLAMP, SURGICAL
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 Key13222167
MDR Text Key284351526
Report Number9710055-2022-00008
Device Sequence Number1
Product Code FTD
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
Type of Report Initial,Followup
Report Date 02/03/2022
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received01/11/2022
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Catalogue NumberARDLCA219001A
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? No
Date Manufacturer Received01/18/2022
Was Device Evaluated by Manufacturer? No
Date Device Manufactured11/16/2018
Is the Device Single Use? No
Type of Device Usage Reuse

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