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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MAQUET SAS VOLISTA STANDOP; LIGHT, SURGICAL, CEILING MOUNTED
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MAQUET SAS VOLISTA STANDOP; LIGHT, SURGICAL, CEILING MOUNTED Back to Search Results
Model Number ARD568821963
Device Problem Leak/Splash (1354)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 06/09/2023
Event Type  malfunction  
Manufacturer Narrative
Additional information will be provided following the conclusion of the investigation.H3 : device not returned to manufacturer.
 
Event Description
On 9th june, 2023 getinge became aware of an issue with one of surgical lights ¿ volista standop.As it was stated the water was dripping from the arms.We decided to report the issue in abundance of caution as contact of water with live parts may cause electric shock and any particles falling off into sterile field or during procedure may cause contamination.
 
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Brand Name
VOLISTA STANDOP
Type of Device
LIGHT, SURGICAL, CEILING MOUNTED
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 Key17169746
MDR Text Key317558962
Report Number9710055-2023-00453
Device Sequence Number1
Product Code FSY
Combination Product (y/n)N
Reporter Country CodePL
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Foreign,User Facility,Company Representative
Reporter Occupation Other
Type of Report Initial
Report Date 06/21/2023
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received06/21/2023
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Model NumberARD568821963
Device Catalogue NumberARD568821963
Was Device Available for Evaluation? Yes
Date Manufacturer Received06/09/2023
Was Device Evaluated by Manufacturer? No
Date Device Manufactured06/10/2016
Is the Device Single Use? No
Type of Device Usage Reuse
Patient Sequence Number1
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