• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

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

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

MAQUET SAS LUCEA 50 LAMP, SURGICAL Back to Search Results
Model Number ARDLCA209012A
Device Problem Electrical /Electronic Property Problem (1198)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Type  malfunction  
Manufacturer Narrative
Issue is being investigated by manufacturing site.
 
Event Description
On (b)(6) 2020 getinge became aware of an issue with one of surgical lights - lucea 50. As it was stated, the electrical connection in a spring arm was faulty creating sparkling sound. There was no injury reported however we decided to report the issue basing on a potential as faulty electrical connection may lead to electrical shock of operator of the device.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

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 Key10419204
MDR Text Key203306786
Report Number9710055-2020-00321
Device Sequence Number1
Product Code FTD
Combination Product (y/n)N
Reporter Country CodeHK
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,Followup,Followup
Report Date 12/15/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received08/18/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberARDLCA209012A
Device Catalogue NumberARDLCA209012A
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? No
Date Manufacturer Received11/19/2021
Was Device Evaluated by Manufacturer? No
Date Device Manufactured01/24/2020
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse

-
-