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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
Device Problem Detachment of Device or Device Component (2907)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 02/20/2019
Event Type  malfunction  
Manufacturer Narrative
The issue is being investigated by manufacturing site. (b)(4).
 
Event Description
On (b)(6) 2019 maquet sas became aware of an issue with one of devices- lucea 50. As it was stated, the spring arm together with the light head fell off. There was no injury reported however we decided to report the issue based on the potential as the parts falling off could lead to an adverse event. Manufacturer's reference number: (b)(4).
 
Manufacturer Narrative
The issue is still being investigated by manufacturing site. (b)(4). Exemption # e2018005. (b)(4).
 
Event Description
Manufacturer's reference number (b)(4).
 
Manufacturer Narrative
The issue is still being investigated by manufacturing site. (b)(4). Exemption # e2018005. (b)(4).
 
Event Description
Manufacturer's reference number: (b)(4).
 
Manufacturer Narrative
The issue is still being investigated by manufacturing site. (b)(4). Exemption # e2018005. (b)(4).
 
Event Description
Manufacturer's reference number (b)(4).
 
Manufacturer Narrative
The issue is still being investigated by manufacturing site. (b)(4). Exemption # e2018005. (b)(4).
 
Event Description
Manufacturer's reference number (b)(4).
 
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Brand NameLUCEA 50
Type of DeviceLAMP, SURGICAL
Manufacturer (Section D)
MAQUET SAS
orléans cedex 2
FR
Manufacturer (Section G)
PASCAL JAY - MAQUET SAS
parc de limère
avenue de la pomme de pi
orléans cedex 2 45074
FR 45074
Manufacturer Contact
parc de limère
avenue de la pomme de pi
orléans cedex 2 45074
0332382587
MDR Report Key8362188
MDR Text Key139063692
Report Number9710055-2019-00042
Device Sequence Number1
Product Code FTD
Combination Product (y/n)N
Reporter Country CodeNL
PMA/PMN Number
K113679
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Reporter Occupation
Remedial Action Replace
Type of Report Initial,Followup,Followup,Followup,Followup
Report Date 07/22/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received02/22/2019
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
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 Received02/20/2019
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

Patient Treatment Data
Date Received: 02/22/2019 Patient Sequence Number: 1
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