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

Model Number	ARDVCS209005A
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/27/2024
Type of Reportable Event	Malfunction
Event or Problem Description
On 27th february, 2024 getinge became aware of an issue with one of surgical lights - volista access.It was stated the lamp was flooded, the device was not in use when the water felt down from upstairs, no surgeries at this time, no patient involved.The water was dropping down from device and was found inside the unit.We decided to report the issue in abundance of caution as any liquid droplets falling off into sterile field or during procedure may cause contamination in case of recurrence and contact of water with live parts may cause electric shock.
Additional Manufacturer Narrative
Event site city: (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.
Event or Problem Description
Manufacturer's reference number (b)(4).
Additional Manufacturer Narrative
The correction of h3a device evaluated by manufacturer, h3b device not eval provide code, h3c if other provide code - explain and h4 manufacture date deems required.This is based on the internal evaluation.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 h4 manufacture date: 2019-11-20.Corrected h4 manufacture date: 2019-11-21.Getinge became aware of an issue with one of surgical lights - volista access.It was stated the lamp was flooded, the device was not in use when the water felt down from upstairs, no surgeries at this time, no patient involved.The water was dropping down from device and was found inside the unit.We decided to report the issue in abundance of caution as any liquid droplets falling off into sterile field or during procedure may cause contamination in case of recurrence 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.Subject matter expert established that according to the information provided the presence of water in the device is the result of a water leakage or excessive cleaning product used from the facility, it is a phenomenon external to the device.This problem is not related to the device, the or 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.

• 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: 18836521
• Report Number: 9710055-2024-00194
• Device Sequence Number: 7533239
• Product Code: FSY
• UDI-Device Identifier: 03700712401313
• UDI-Public: (01)03700712401313
• Combination Product (Y/N): N
• Initial Reporter Country: SP
• 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): 07/08/2024

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: ARDVCS209005A
• Device Catalogue Number: ARDVCS209005A
• 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: 02/27/2024
• Supplement Date Received by Manufacturer: 07/02/2024
• Initial Report FDA Received Date: 03/05/2024
• Supplement Report FDA Received Date: 07/10/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/21/2019
• Is the Device Labeled for Single Use? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown