Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MAQUET SAS VOLISTA STANDOP; LAMP, SURGICAL
  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

MAQUET SAS VOLISTA STANDOP; LAMP, SURGICAL Back to Search Results
Model Number ARD568821961
Device Problem Positioning Failure (1158)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 07/19/2023
Event Type  malfunction  
Manufacturer Narrative
Additional information will be provided following the conclusion of the investigation.H3 other text : device not returned to manufacturer.
 
Event Description
On 19th january, 2023 getinge became aware of an issue with one of surgical lights - volista standop.It was stated the device was drifting down and reach the user.We decided to report the issue in abundance of caution as contact of the medical device with sterile medical staff during procedure may cause contamination of the sterile medical staff.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand Name
VOLISTA STANDOP
Type of Device
LAMP, 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 Key17432840
MDR Text Key320149631
Report Number9710055-2023-00563
Device Sequence Number1
Product Code FTD
Combination Product (y/n)N
Reporter Country CodeCA
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 08/01/2023
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received08/01/2023
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Model NumberARD568821961
Device Catalogue NumberARD568821961
Was Device Available for Evaluation? Yes
Date Manufacturer Received07/19/2023
Was Device Evaluated by Manufacturer? No
Date Device Manufactured05/02/2016
Is the Device Single Use? No
Type of Device Usage Reuse
Patient Sequence Number1
-
-