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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MAQUET SAS LUCEA LAMP, SURGICAL

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MAQUET SAS LUCEA LAMP, SURGICAL Back to Search Results
Model Number ARDLCA209015A
Device Problem Loose or Intermittent Connection (1371)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 05/08/2020
Event Type  malfunction  
Manufacturer Narrative
Issue is being investigated by manufacturing site. Device not returned to manufacturer.
 
Event Description
On 8th may, 2020 getinge became aware of customer product complaint where an issue occurred with one of surgical lights - lucea 50. The lamp was initially diagnosed with problem related to shaking. Further evaluation revealed that it was caused by loose connection between spring arm and main tube (loosened screws). There was no patient injury, however we decided to report the issue in abundance of caution as loosened screws may lead to detachment of the lamp or its components.
 
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Brand NameLUCEA
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 Key10085132
MDR Text Key192043256
Report Number9710055-2020-00161
Device Sequence Number1
Product Code FTD
Combination Product (y/n)N
Reporter Country CodeSN
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 07/16/2020
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received05/25/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberARDLCA209015A
Device Catalogue NumberARDLCA209015A
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 Received07/16/2020
Was Device Evaluated by Manufacturer? No
Date Device Manufactured11/01/2016
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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