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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MAQUET SAS VOLISTA STANDOP LAMP, SURGICAL

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MAQUET SAS VOLISTA STANDOP LAMP, SURGICAL Back to Search Results
Model Number ARD568811910
Device Problem Peeled/Delaminated (1454)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
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 one of surgical lights - volista standop. As getinge was informed, the paint was peeling from spring arm. We decided to report the issue in abundance of caution as any paint particles falling off into sterile field or during procedure may cause contamination.
 
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Brand NameVOLISTA STANDOP
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 Key12615345
MDR Text Key277113429
Report Number9710055-2021-00328
Device Sequence Number1
Product Code FTD
Combination Product (y/n)N
Reporter Country CodeUK
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Foreign,User Facility,Company Representative
Reporter Occupation Biomedical Engineer
Type of Report Initial,Followup
Report Date 11/05/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received10/12/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Model NumberARD568811910
Device Catalogue NumberARD568811910
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? Yes
Date Manufacturer Received10/11/2021
Was Device Evaluated by Manufacturer? No
Date Device Manufactured11/10/2015
Is the Device Single Use? No
Type of Device Usage Reuse

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