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U.S. Department of Health and Human Services

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

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MAQUET SAS LUCEA 50 LAMP, SURGICAL Back to Search Results
Model Number ARD2LCA0005
Device Problem Detachment of Device or Device Component (2907)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 06/11/2021
Event Type  malfunction  
Manufacturer Narrative
Additional information will be provided following the conclusion of the investigation. Device not returned to manufacturer.
 
Event Description
On (b)(6) 2021 getinge became aware of an issue with surgical light ¿ lucea 50. As it was stated in the customer product complaint (b)(4), the transparent cover has detached from the headlight. As we were informed, the issue occurred on delivery room, after the delivery. Patient¿s husband noticed the light head was defective and removed the device from the treatment¿s area, then the detachment occurred. We were also informed by bfarm about the issue and it¿s circumstances on (b)(6) 2021. It was described, that when the lamp was moved into the cabinet, the transparent cover of the lamp fell down. Fortunately, the woman's partner reacted quickly and caught the cover, otherwise it would have fallen on the child. There was no injury reported however we decided to report the issue in abundance of caution as any parts falling may lead to serious injury.
 
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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 Key12016242
MDR Text Key256828126
Report Number9710055-2021-00221
Device Sequence Number1
Product Code FTD
Combination Product (y/n)N
Reporter Country CodeGM
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 11/03/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received06/17/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberARD2LCA0005
Device Catalogue NumberARD368609996
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 Received10/20/2021
Was Device Evaluated by Manufacturer? No
Date Device Manufactured05/15/2020
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device?
Type of Device Usage Reuse

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