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

Model Number ARDVCS209004A

Device Problem Fluid/Blood Leak (1250)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Type  malfunction  

Event Description

On 24th january, 2024 getinge became aware of an issue with one of surgical lights - volista access.It was stated the rainwater infilted through the ceiling, reached the main tube and also wetting the ceiling power supplies, damaging them.We decided to report the issue in abundance of caution as any liquid falling off into sterile field or during procedure may cause contamination and contact of water with live parts may cause electric shock.

Manufacturer Narrative

Event site name: (b)(6).Additional information will be provided following the conclusion of the investigation.H3 other text : device not returned to manufacturer.

• Brand Name: VOLISTA ACCESS
• 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 Key: 18604717
• MDR Text Key: 334025248
• Report Number: 9710055-2024-00098
• Device Sequence Number: 1
• Product Code: FSY
• Combination Product (y/n): N
• Reporter Country Code: BR
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,User Facility,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 01/30/2024

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 Number: ARDVCS209004A
• Device Catalogue Number: ARDVCS209004A
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: 01/24/2024
• Initial Date FDA Received: 01/30/2024
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 11/03/2021
• Is the Device Single Use?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1