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U.S. Department of Health and Human Services

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

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MAQUET SAS VOLISTA STANDOP 600 LAMP, SURGICAL Back to Search Results
Model Number ARD568811911
Device Problem Detachment of Device or Device Component (2907)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 04/20/2022
Event Type  malfunction  
Manufacturer Narrative
Additional information will be provided following the conclusion of the investigation. Device not returned to manufacturer.
 
Event Description
On 20th april, 2022 getinge became aware of an issue with one of surgical lights - volista standop 600. It was stated that cover was missing. We decided to report the issue in abundance of caution as any parts falling off into sterile field or during procedure may cause contamination.
 
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Brand NameVOLISTA STANDOP 600
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 Key14185534
MDR Text Key289968235
Report Number9710055-2022-00132
Device Sequence Number1
Product Code FTD
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type User Facility,Company Representative
Reporter Occupation Biomedical Engineer
Type of Report Initial,Followup,Followup
Report Date 04/22/2022
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received04/22/2022
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Model NumberARD568811911
Device Catalogue NumberARD568811911
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? Yes
Date Manufacturer Received07/01/2022
Was Device Evaluated by Manufacturer? No
Date Device Manufactured12/14/2015
Is the Device Single Use? No
Type of Device Usage Reuse

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