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U.S. Department of Health and Human Services

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

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MAQUET SAS LUCEA LIGHT, SURGICAL, CEILING MOUNTED Back to Search Results
Catalog Number ARD568601997
Device Problem Crack (1135)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 09/19/2018
Event Type  Malfunction  
Manufacturer Narrative

The issue is being investigated by manufacturing site. (b)(4).

 
Event Description

On (b)(4) 2018 maquet (b)(4) became aware of an incident with one of surgical lights- lucea. As it was stated, the lights are cracking on the screws and there is a possibility that the particles could fall. There is no injury reported however we decided to report the issue in abundance of caution as any particle falling might be a source of contamination. (b)(4).

 
Manufacturer Narrative

The issue is still being investigated by manufacturing site.

 
Event Description

(b)(4).

 
Manufacturer Narrative

The issue is still being investigated by manufacturing site.

 
Event Description

Manufacturer reference number (b)(4).

 
Manufacturer Narrative

The issue is still being investigated by manufacturing site. (b)(4). Exemption # e2018005. (b)(4).

 
Event Description

Manufacturer reference number (b)(4).

 
Manufacturer Narrative

The issue is still being investigated by manufacturing site. (b)(4). Exemption # e2018005. (b)(4).

 
Event Description

Manufacturer reference number (b)(4).

 
Manufacturer Narrative

The issue is still being investigated by manufacturing site. (b)(4). Exemption # e2018005. (b)(4).

 
Event Description

Manufacturer reference number (b)(4).

 
Manufacturer Narrative

The issue is still being investigated by manufacturing site. (b)(4). Exemption # e2018005. (b)(4).

 
Event Description

Manufacturer reference number (b)(4).

 
Manufacturer Narrative

The issue is still being investigated by manufacturing site. (b)(4). Exemption # e2018005. (b)(4).

 
Event Description

Manufacturer reference number (b)(4).

 
Manufacturer Narrative

The issue is still being investigated by manufacturing site. (b)(4). Exemption # e2018005. (b)(4).

 
Event Description

Manufacturer reference number (b)(4).

 
Manufacturer Narrative

The issue is still being investigated by manufacturer's site. (b)(4). Exemption # e2018005. (b)(4).

 
Event Description

Manufacturer reference number (b)(4).

 
Manufacturer Narrative

The issue is still being investigated by manufacturing site. (b)(4). Exemption # e2018005. (b)(4).

 
Event Description

Manufacturer reference number (b)(4).

 
Manufacturer Narrative

The issue is still being investigated by manufacturing site.

 
Event Description

Manufacturer reference number: (b)(4).

 
Manufacturer Narrative

The issue is still being investigated by manufacturing site.

 
Event Description

Manufacturer reference number (b)(4).

 
Manufacturer Narrative

(b)(4). Exemption # e2018005. (b)(4). The issue is still being investigated by manufacturing site.

 
Event Description

Manufacturer reference number (b)(4).

 
Manufacturer Narrative

The issue is still being investigated by manufacturing site.

 
Event Description

Manufacturer reference number (b)(4).

 
Manufacturer Narrative

The issue is still being investigated by manufacturing site.

 
Event Description

Manufacturer reference number: (b)(4).

 
Manufacturer Narrative

The issue is still investigated by manufacturing site. (b)(4). Exemption # e2018005. (b)(4).

 
Event Description

Manufacturer reference number (b)(4).

 
Search Alerts/Recalls

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Brand NameLUCEA
Type of DeviceLIGHT, SURGICAL, CEILING MOUNTED
Manufacturer (Section D)
MAQUET SAS
orléans cedex 2
FR
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 
0332382587
MDR Report Key7984491
MDR Text Key124546800
Report Number9710055-2018-00130
Device Sequence Number1
Product Code FSY
Combination Product (Y/N)N
PMA/PMN NumberK113679
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type COMPANY REPRESENTATIVE
Reporter Occupation OTHER HEALTH CARE PROFESSIONAL
Remedial Action Replace
Type of Report Initial,Followup,Followup,Followup,Followup
Report Date 02/27/2020
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received10/19/2018
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device Catalogue NumberARD568601997
Was Device Available For Evaluation? Yes
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA?
Device Ageyr
Event Location No Information
Date Manufacturer Received02/13/2020
Was Device Evaluated By Manufacturer? Yes
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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