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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 ARDVST229019A
Device Problems Crack (1135); Detachment of Device or Device Component (2907)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 04/10/2024
Event Type  malfunction  
Event Description
On 10th april, 2024 getinge became aware of an issue with one of surgical lights - volista standop.It was stated and confirmed by photographic evidence that aluminum arm holding the headlight was cracked with risk of detachment.According to the getinge technician input no one was injured as a result of this failure.We decided to report the issue in abundance of caution as cracked holding arm could result in detachment of arm and headlight and as a result of that, could lead to serious injury in case of reoccurrence.
 
Manufacturer Narrative
E1b event site name:(b)(6) additional information will be provided following the conclusion of the investigation.
 
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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 Key19172779
MDR Text Key341634666
Report Number9710055-2024-00292
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 04/24/2024
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received04/24/2024
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Model NumberARDVST229019A
Device Catalogue NumberARDVST229019A
Was Device Available for Evaluation? Yes
Date Manufacturer Received04/10/2024
Was Device Evaluated by Manufacturer? No
Date Device Manufactured11/05/2020
Is the Device Single Use? No
Type of Device Usage Reuse
Patient Sequence Number1
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