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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
Model Number LUCEA 50/100
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 one of surgical lights - lucea. The fell of the upper and lower covers occurred. We decided to report the issue in abundance of caution as any part falling off into sterile field or during procedure may cause contamination.
 
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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 Key13076900
MDR Text Key282713209
Report Number9710055-2021-00383
Device Sequence Number1
Product Code FTD
Combination Product (y/n)N
Reporter Country CodeFR
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,Followup
Report Date 03/09/2022
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received12/23/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Model NumberLUCEA 50/100
Device Catalogue NumberARD568604998
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? No
Date Manufacturer Received02/16/2022
Was Device Evaluated by Manufacturer? No
Date Device Manufactured04/09/2020
Is the Device Single Use? No
Type of Device Usage Reuse

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