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

Model Number	ARDVCS209004A
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Event or Problem 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.
Additional 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.
Additional Manufacturer Narrative
The correction of h4 manufacture date, d4 catalog #, d4 unique identifier (udi), h3a device evaluated by manufacturer, h3b device not eval provide code, h3c if other provide code - explain fields, b5 describe event and problem deems required.This is based on the internal evaluation.Previous h4 manufacture date: 2021-11-03.Corrected h4 manufacture date: 2021-11-04.Previous d4 unique identifier (udi) #: n/a.Corrected d4 unique identifier (udi) #: (b)(4).Previous d4 catalog # ardvcs209004a.Previous h3a device evaluated by manufacturer: no.Corrected h3a device evaluated by manufacturer: yes.Previous h3b device not eval provide code: other.Corrected h3b device not eval provide code: n/a.Previous h3c if other provide code - explain: device not returned to manufacturer.Corrected h3c if other provide code - explain: n/a.Previous b5 describe event and problem: 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, damageing 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.Corrected b5 describe event and problem: on 24th january, 2024 getinge became aware of an issue with one of surgical lights - volista access.It was stated the rainwater filtered through the ceiling, reached the main tube and also wetting the ceiling power supplies, damageing 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.Getinge became aware of an issue with one of surgical lights - volista access.It was stated the rainwater filtered through the ceiling, reached the main tube and also wetting the ceiling power supplies, damageing 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.Based on the information collected, it was established that when the event occurred, the surgical light did not meet its specification and in this way the device contributed to event.The device was not being used for patient treatment upon the event occurrence.Root cause analysis was performed by subject matter expert at manufacturer¿s.The analysis is following: according to the information provided the presence of water in the device is certainly the result of a water leakage from the facility, it is a phenomenon external to the device.This problem is not related to the device, the volista surgical light is not supplied with water and is not a source of a leak.For safety reasons a functional check of the device is required to verify the absence of damage.Getinge shall continue to monitor for any further events of this nature and does not propose any further action at this time.
Event or Problem Description
On 24th january, 2024 getinge became aware of an issue with one of surgical lights - volista access.It was stated the rainwater filtered 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.

• Brand Name: VOLISTA ACCESS
• Common Device Name: 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
• Report Number: 9710055-2024-00098
• Device Sequence Number: 21090882
• Product Code: FSY
• UDI-Device Identifier: 03700712401320
• UDI-Public: (01)03700712401320
• Combination Product (Y/N): N
• Initial Reporter Country: BR
• PMA/510(K) Number: K130513
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,User Facility,Company Representative
• Initial Reporter Occupation: Biomedical Engineer
• Type of Report: Initial,Followup
• Report Date (Section B): 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
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/24/2024
• Supplement Date Received by Manufacturer: 09/05/2024
• Initial Report FDA Received Date: 01/30/2024
• Supplement Report FDA Received Date: 09/06/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/04/2021
• Is the Device Labeled for Single Use? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown