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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 ARD568603902
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 24th of august 2021 getinge became aware of an issue with volista standop device. The layer of keypad was peeled. There was no injury reported however, we decided to report the issue in abundance of caution as any 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 Key12370100
MDR Text Key268221057
Report Number9710055-2021-00292
Device Sequence Number1
Product Code FTD
Combination Product (y/n)N
Reporter Country CodeLO
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Foreign,User Facility,Company Representative
Reporter Occupation
Type of Report Initial,Followup,Followup
Report Date 09/28/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received08/26/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Model NumberARD568603902
Device Catalogue NumberARD568851961
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? Yes
Date Manufacturer Received08/03/2022
Was Device Evaluated by Manufacturer? No
Date Device Manufactured02/03/2021
Is the Device Single Use? No
Type of Device Usage Reuse

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