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

Model Number	ARDVST229003A
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/02/2023
Type of Reportable Event	Malfunction
Event or Problem Description
On 2nd august, 2023 getinge became aware of an issue with one of surgical lights - volista standop.It was stated the excessive moisture has accumulated in the unit from the ceiling and cleaning activities.We decided to report the issue in abundance of caution as contact of water with live parts may cause electric shock.
Additional Manufacturer Narrative
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 initial reporter was or manager.The correction of d1 brand name, d2b product code, d4 version of model #, d4 catalog #, h3a device evaluated by manufacturer?, h3b device not eval provide code and h3c if other provide code -explain, h4 manufacture date fields deems required.This is based on the internal evaluation.Previous d1 brand name: volista standop.Corrected d1 brand name: standop volista®.Previous d2b product code: ftd.Corrected d2b product code: fsy.Previous d4 version of model # ard568821961.Corrected d4 version of model # ardvst229003a.Previous d4 catalog #: ard568821961.Corrected d4 catalog #: blank.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: 2016-11-18.Corrected h4 manufacture date: 2016-11-21.Getinge became aware of an issue with one of surgical lights - volista standop.It was stated the excessive moisture has accumulated in the unit from the ceiling and cleaning activities.We decided to report the issue in abundance of caution as 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.It is unknown if claimed devices were or were not being used for patient treatment or diagnosis when the event took place.Root cause analysis was performed by subject matter expert at manufacturer¿s.The analysis is following: the presence of rust is probably the result of a flood or a condensation in the ceiling of the facility , it is a phenomenon external to the device.This problem is not related to the device.Getinge shall continue to monitor for any further events of this nature and does not propose any further action at this time.

• Brand Name: STANDOP VOLISTA®
• 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: 17562486
• Report Number: 9710055-2023-00589
• Device Sequence Number: 15188401
• Product Code: FSY
• UDI-Device Identifier: 03700712401726
• UDI-Public: (01)03700712401726
• Combination Product (Y/N): N
• Initial Reporter State: ME
• Initial Reporter Country: US
• PMA/510(K) Number: K130513
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: User Facility,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 08/17/2023

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: ARDVST229003A
• Device Catalogue Number: ARD568821961
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/02/2023
• Supplement Date Received by Manufacturer: 09/05/2024
• Initial Report FDA Received Date: 08/17/2023
• Supplement Report FDA Received Date: 09/10/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/21/2016
• Is the Device Labeled for Single Use? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown