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

Model Number	ARDVCS209002A
Medical Device Problem Code	Unexpected Shutdown (4019)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/05/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Additional information will be provided following the conclusion of the investigation.H3 other text : device not returned to the manufacturer.
Event or Problem Description
On (b)(6) 2023 getinge became aware of an issue with one of surgical lights - volista access.It was stated the lamp turned off while working.When the customer pressed the button on the keypad again, the lamp started to work and then did not go out.The second lamp was not available in the configuration.During service visit no fault related to the complaint was found, but it was seen the pilot board error within the same day occurred.The device was tested for 14 days in working conditions, the malfunction did not recur.There was no injury reported, however, we decided to report the issue in abundance of caution as the turning off the lamp during procedure may cause serious injury in case of event reoccurrence.
Event or Problem Description
Manufacturer's reference number (b)(4).
Additional Manufacturer Narrative
Event site telephone: (b)(6).The correction of h3a device evaluated by manufacturer, h3b device not eval provide code, h3c if other provide code - explain fields 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.The correction of d4 catalog # deems required.This is based on the internal evaluation.Previous d4 catalog # ardvcs209002a.Corrected d4 catalog # blank.Getinge became aware of an issue with one of surgical lights - volista access.It was stated the lamp turned off while working.When the customer pressed the button on the keypad again, the lamp started to work and then did not go out.The second lamp was not available in the configuration.During service visit no fault related to the complaint was found, but it was seen the pilot board error within the same day occurred.The device was tested for 14 days in working conditions, the malfunction did not recur.There was no injury reported, however, we decided to report the issue in abundance of caution as the turning off the lamp during procedure may cause serious injury in case of event reoccurrence.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 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: the single light turned off during use.When they pressed the button on the keypad again, the lamp started to work and then did not go out.No power outages were reported prior to use.No malfunction related to the complaint was found, but it was seen that the device gave a pilot board error on the same day.* dac reset was performed by connecting the device to the service interface.After the process, the lighting parameters were adjusted again.The study was terminated as the malfunction did not recur after the intervention made on the device tested for 14 days.The device was delivered in working condition.The volista instruction for use ifu 01781 defines a single light as a minor surgical light: "single light located in the patient¿s environment in an operating room and designed to facilitate treatment and diagnosis procedures which can be interrupted without compromising patient safety in the event of a light failure".To prevent any incident the volista instruction for use ifu 01781 mentions several warning, recommendation, caution and note concerning a switching off light."warning! risk of injury/infection.The use of a damaged device may lead to a risk of injury for users or a risk of infection for patients.Do not use a damaged device"."warning! risk of injury.If a power cut occurs in the middle of an operation, the lightheads will go out if the lighting system does not have a backup supply.The hospital must comply with applicable standards on premises for medical use and must have a backup power system"."note electromagnetic interference may result in temporary extinction or temporary flickering of the light, which will resume its initial operation once the interference has ceased"."caution! risk of malfunction of the device.The use of a high frequency generator (e.G.Electrosurgical unit) adjacent to the device may affect its operation and performance.If anomalous operation is observed, adjust the position of the lightheads until the interference ceases"."caution! risk of malfunction of the device.If the device is used in conjunction with other equipment, its operation and performance may be affected.Do not use the device alongside other equipment or stacked with other equipment except after observing the normal operation of the device and the other equipment"."to ensure that the product used is compliant, various visual and functional inspections must be performed.Check that the lighthead responds to keypad commands by adjusting the illumination of the lighthead from the minimum to the maximum setting".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: 17048384
• Report Number: 9710055-2023-00419
• Device Sequence Number: 5178107
• Product Code: FSY
• UDI-Device Identifier: 03700712401344
• UDI-Public: (01)03700712401344
• Combination Product (Y/N): N
• Initial Reporter Country: TU
• 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): 06/02/2023

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: ARDVCS209002A
• Device Catalogue Number: ARDVCS209002A
• 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: 05/05/2023
• Supplement Date Received by Manufacturer: 08/06/2024
• Initial Report FDA Received Date: 06/02/2023
• Supplement Report FDA Received Date: 08/14/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/16/2018
• Is the Device Labeled for Single Use? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown