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U.S. Department of Health and Human Services

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

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MAQUET SAS VOLISTA LIGHT, SURGICAL, CEILING MOUNTED Back to Search Results
Model Number ARD567910990
Device Problems Material Discolored (1170); Material Erosion (1214)
Patient Problem No Information (3190)
Event Date 05/02/2018
Event Type  Malfunction  
Manufacturer Narrative

(b)(4). The issue is being 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 by the technician, the main arm started to rust. There was no injury or contamination reported however we decided to report the issue in abundance of caution. (b)(4).

 
Manufacturer Narrative

(b)(4). Exemption # e2018005. (b)(4). The issue will be investigated by manufacturing site.

 
Event Description

Manufacturer reference number (b)(4).

 
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Brand NameVOLISTA
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 Key7548801
MDR Text Key109628087
Report Number9710055-2018-00037
Device Sequence Number1
Product Code FSY
Combination Product (Y/N)N
Reporter Country CodeIN
PMA/PMN NumberK130513
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type COMPANY REPRESENTATIVE,FOREIG
Reporter Occupation BIOMEDICAL ENGINEER
Type of Report Initial,Followup,Followup
Report Date 07/17/2018
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received05/29/2018
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device MODEL NumberARD567910990
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 Received05/02/2018
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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