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U.S. Department of Health and Human Services

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

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MAQUET SAS LUCEA 50 LAMP, SURGICAL Back to Search Results
Model Number ARDLCA109004A
Device Problem Detachment of Device or Device Component (2907)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 03/31/2022
Event Type  malfunction  
Event Description
On (b)(6) 2022 getinge became aware of an issue with one of surgical lights, lucea 50. It was stated the headlight cover was cracked and the particles was missing. We decided to report the issue in abundance of caution as any 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. Device not returned to manufacturer.
 
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Brand NameLUCEA 50
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 Key14013363
MDR Text Key288590420
Report Number9710055-2022-00109
Device Sequence Number1
Product Code FTD
Combination Product (y/n)N
Reporter Country CodeUK
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 04/05/2022
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received04/05/2022
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Model NumberARDLCA109004A
Device Catalogue NumberARD368609996
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? No
Date Manufacturer Received06/14/2022
Was Device Evaluated by Manufacturer? No
Date Device Manufactured11/21/2019
Is the Device Single Use? No
Type of Device Usage Reuse

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