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

Model Number ARD568821911

Device Problem Leak/Splash (1354)

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

Event Date 01/18/2023

Event Type  malfunction  

Manufacturer Narrative

Additional information will be provided following the conclusion of the investigation.Initial reporter name:(b)(6) med ctr.Device not returned to manufacturer.

Event Description

On 18th january 2023 getinge became aware of an issue with one of our surgical lights - volista standop 600.As it was stated, the power supply was damaged by water leak.There was no injury reported, however, we decided to report the issue in abundance of caution as contact of water with live parts may cause electric shock.

Event Description

Manufacturer's reference number (b)(4).

Manufacturer Narrative

Getinge became aware of an issue with one of our surgical lights - volista standop 600.As it was stated, the power supply was damaged by water leak.There was no injury reported, however, we decided to report the issue in abundance of caution as contact of water with live parts may cause electric shock.Based on an information provided by getinge technician, device was repaired and released for use.It was established that when the event occurred, the surgical light did not meet its specification, since presence of water affects surgical light¿s functionality and safety, and in this way, the device contributed to event.According to the information gathered, the issue was discovered during daily checking.When reviewing similar reportable events for the same device type, we have been able to confirm that the investigated issue has never led to serious injury or worse, to our knowledge.Comparing the number of complained devices to the install base of the volista range, we can conclude the failure ratio is very low.A root cause analysis was performed by subject matter expert at the manufacturing site.As they stated, according to the information provided the presence of water in the power supply of the surgical light is the result of a water leakage from the ceiling of the facility.It is a phenomenon external to the device.This problem is not related to the device since the volista surgical light itself is not supplied with water and is not a source of a leak.We believe the related devices are performing correctly in the market, as the issue occurred due to the customer¿s facility issue.

• Brand Name: VOLISTA STANDOP
• 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: 16310267
• MDR Text Key: 308919171
• Report Number: 9710055-2023-00093
• Device Sequence Number: 1
• Product Code: FSY
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: User Facility,Company Representative
• Reporter Occupation: Biomedical Engineer
• Type of Report: Initial,Followup
• Report Date: 02/07/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/07/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Model Number: ARD568821911
• Device Catalogue Number: ARD568821911
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/04/2023
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 08/02/2017
• Is the Device Single Use?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1