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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 ARDLCA219001A
Device Problem Overheating of Device (1437)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 04/28/2022
Event Type  malfunction  
Event Description
On 28th of april, 2022 getinge became aware of an issue with lucea 100 - surgical light. As it was stated, connection between spring arm and fork has overheated. There was no injury reported, however, we decided to report the issue in abundance of caution as overheating may cause fire.
 
Manufacturer Narrative
Additional information will be provided following the conclusion of the investigation. Device not returned to manufacturer.
 
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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 Key14315221
MDR Text Key291482933
Report Number9710055-2022-00146
Device Sequence Number1
Product Code FTD
Combination Product (y/n)N
Reporter Country CodeCA
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 05/06/2022
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received05/07/2022
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Model NumberARDLCA219001A
Device Catalogue NumberARDLCA219001A
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? No
Date Manufacturer Received05/20/2022
Was Device Evaluated by Manufacturer? No
Date Device Manufactured02/20/2017
Is the Device Single Use? No
Type of Device Usage Reuse

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