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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MAQUET SAS LUCEA 100 LIGHT, SURGICAL, CEILING MOUNTED

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MAQUET SAS LUCEA 100 LIGHT, SURGICAL, CEILING MOUNTED Back to Search Results
Model Number ARDLCA219001A
Device Problems Crack (1135); 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 24th february, 2021 getinge became aware of an issue with lucea 100 surgical light. As it was stated, the covers were cracked and particles were missing. There was no injury reported, however we decided to report the issue in abundance of caution as any particles falling off into steriel field or during procedure may cause contamination.

 
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Brand NameLUCEA 100
Type of DeviceLIGHT, SURGICAL, CEILING MOUNTED
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 Key11435777
MDR Text Key239161348
Report Number9710055-2021-00082
Device Sequence Number1
Product Code FSY
Combination Product (Y/N)N
Reporter Country CodeBR
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type COMPANY REPRESENTATIVE,FOREIG
Reporter Occupation
Type of Report Initial,Followup
Report Date 04/01/2021
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received03/08/2021
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator NO INFORMATION
Device MODEL NumberARDLCA219001A
Device Catalogue NumberARDLCA219001A
Was Device Available For Evaluation? Yes
Is The Reporter A Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received03/11/2021
Was Device Evaluated By Manufacturer? No
Date Device Manufactured11/20/2018
Is The Device Single Use? No
Is this a Reprocessed and Reused Single-Use Device?
Type of Device Usage Reuse

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