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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MAQUET SAS VOLISTA ACCESS II; LIGHT, SURGICAL, CEILING MOUNTED

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MAQUET SAS VOLISTA ACCESS II; LIGHT, SURGICAL, CEILING MOUNTED Back to Search Results
Model Number ARDVCS209030A
Device Problem Fluid/Blood Leak (1250)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 02/16/2024
Event Type  malfunction  
Event Description
On 16th february, 2024 getinge became aware of an issue with one of surgical lights - volista access ii.It was stated the water was leaking from the ceiling, after breakage of water system pipe and the damage certainly spread within the electrical circuitry and on the rotating contacts inside the suspension arms.It was confirmed by photographic evidence the the water has infiltrated inside the dome.We decided to report the issue in abundance of caution as contact of water with live parts may cause electric shock.
 
Manufacturer Narrative
Event site name: (b)(6).Event site telephone: (b)(6).Additional information will be provided following the conclusion of the investigation.H3 other text : device not returned to manufacturer.
 
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Brand Name
VOLISTA ACCESS II
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 Key18798127
MDR Text Key337152567
Report Number9710055-2024-00182
Device Sequence Number1
Product Code FSY
Combination Product (y/n)N
Reporter Country CodeIT
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 02/28/2024
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Model NumberARDVCS209030A
Device Catalogue NumberARDVCS209030A
Was Device Available for Evaluation? Yes
Initial Date Manufacturer Received 02/16/2024
Initial Date FDA Received02/28/2024
Was Device Evaluated by Manufacturer? No
Date Device Manufactured09/04/2023
Is the Device Single Use? No
Type of Device Usage Reuse
Patient Sequence Number1
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