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U.S. Department of Health and Human Services

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

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MAQUET SAS VOLISTA STANDOP LIGHT, SURGICAL, CEILING MOUNTED Back to Search Results
Catalog Number ARD568811951
Device Problem Detachment Of Device Component (1104)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 04/04/2018
Event Type  Malfunction  
Manufacturer Narrative

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

 
Event Description

On (b)(4) 2018 maquet (b)(4) became aware of an incident with one of surgical lights- volista. As it was stated, the bumper fell off during surgery. There was no injury reported.

 
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Brand NameVOLISTA STANDOP
Type of DeviceLIGHT, SURGICAL, CEILING MOUNTED
Manufacturer (Section D)
MAQUET SAS
orléans cedex 2
FR
Manufacturer (Section G)
FREDERIC LELEU - 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 Key7471974
MDR Text Key107195571
Report Number9710055-2018-00023
Device Sequence Number1
Product Code FSY
Combination Product (Y/N)N
Reporter Country CodeFR
PMA/PMN NumberK130513
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type COMPANY REPRESENTATIVE,FOREIG
Reporter Occupation OTHER HEALTH CARE PROFESSIONAL
Type of Report Initial,Followup
Report Date 05/29/2018
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received04/30/2018
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device Catalogue NumberARD568811951
Was Device Available For Evaluation? Yes
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received04/05/2018
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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