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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MAQUET SAS LUCEA 50 LIGHT, SURGICAL, CEILING MOUNTED

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MAQUET SAS LUCEA 50 LIGHT, SURGICAL, CEILING MOUNTED Back to Search Results
Model Number ARDLCA309004A
Device Problem Crack (1135)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Type  Malfunction  
Manufacturer Narrative

Additional information will be provided following the conclusion of the investigation. Device not returned to manufacturer.

 
Event Description

On 23rd february, 2021 getinge became aware of an issue with lucea 50 surgical light. The cover of light head was cracked and particles were missing. The issue was in line with photographic evidence. There was no injury reported, however, we decided to report the complaint in abundance of caution as any particles or parts falling off into sterile field or during procedure may cause contamination.

 
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Brand NameLUCEA 50
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 Key11378583
MDR Text Key233555606
Report Number9710055-2021-00076
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,Followup
Report Date 05/10/2021
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received02/25/2021
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator NO INFORMATION
Device MODEL NumberARDLCA309004A
Device Catalogue NumberARDLCA309004A
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 Received05/07/2021
Was Device Evaluated By Manufacturer? No
Is The Device Single Use? No
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse

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