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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 ARDLCA109008A
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.
 
Event Description
On (b)(6) 2022 getinge became aware of an issue with one of surgical lights - lucea 100. As it was stated, the headlight cover was damaged. Moreover, during the visit in customer¿s facility on (b)(6) 2022 it was noticed that the particles of the cover were 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.
 
Event Description
On (b)(6) 2022 getinge became aware of an issue with one of surgical lights - lucea 100. As it was stated, the headlight cover was damaged. Moreover, during the visit in customer¿s facility on (b)(6) 2022 it was noticed that the particles of the cover were 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.
 
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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 Key13590993
MDR Text Key286059551
Report Number9710055-2022-00068
Device Sequence Number1
Product Code FTD
Combination Product (y/n)N
Reporter Country CodeEZ
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 03/23/2022
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received02/24/2022
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Model NumberARDLCA109008A
Device Catalogue NumberARD568603999
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? No
Date Manufacturer Received03/03/2022
Was Device Evaluated by Manufacturer? No
Date Device Manufactured09/05/2017
Is the Device Single Use? No
Type of Device Usage Reuse

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