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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MAQUET SAS VOLISTA STANDOP 600 / 400 LAMP, SURGICAL

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MAQUET SAS VOLISTA STANDOP 600 / 400 LAMP, SURGICAL Back to Search Results
Model Number ARD568811910 / ARD568812910
Device Problems Corroded (1131); Peeled/Delaminated (1454)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 04/05/2022
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) 2022 getinge became aware of an issue with one of surgical lights - volista standop. Corrosion has built up on the device and the paint was peeling. We decided to report the issue in abundance of caution as any rust or paint particles falling off into sterile field or during procedure may cause contamination.
 
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Brand NameVOLISTA STANDOP 600 / 400
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 Key14051770
MDR Text Key288864712
Report Number9710055-2022-00113
Device Sequence Number1
Product Code FTD
Combination Product (y/n)N
Reporter Country CodeFR
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,Followup
Report Date 04/08/2022
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received04/08/2022
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Model NumberARD568811910 / ARD568812910
Device Catalogue NumberARD568811910 / ARD568812910
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? Yes
Date Manufacturer Received04/25/2022
Was Device Evaluated by Manufacturer? No
Date Device Manufactured11/04/2015
Is the Device Single Use? No
Type of Device Usage Reuse

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