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U.S. Department of Health and Human Services

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

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MAQUET SAS LUCEA 100 LAMP, SURGICAL Back to Search Results
Model Number ARD568603999
Device Problem Detachment of Device or Device Component (2907)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 04/15/2022
Event Type  malfunction  
Manufacturer Narrative
Additional information will be provided following the conclusion of the investigation. Device not returned to manufacturer.
 
Event Description
On 15th april, 2022 getinge became aware of an issue with lucea 100 surgical light. As it was stated, the headlight detached and fell. There was no injury reported, however, we decided to report the issue in abundance of caution as detachment of the headlight or other parts can lead to serious injury in case of event reoccurrence.
 
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Brand NameLUCEA 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 Key14165796
MDR Text Key289725076
Report Number9710055-2022-00131
Device Sequence Number1
Product Code FTD
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type User Facility,Company Representative
Reporter Occupation
Type of Report Initial
Report Date 04/21/2022
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received04/21/2022
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Model NumberARD568603999
Device Catalogue NumberARD568603999
Was Device Available for Evaluation? Yes
Date Manufacturer Received04/15/2022
Was Device Evaluated by Manufacturer? No
Date Device Manufactured03/26/2014
Is the Device Single Use? No
Type of Device Usage Reuse

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