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

Model Number ARDVCS209018A

Device Problem Grounding Malfunction (1271)

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

Event Date 11/29/2023

Event Type  malfunction  

Manufacturer Narrative

Additional information will be provided following the conclusion of the investigation.H3 other text : device not returned to manufacturer.

Event Description

On 29th november, 2023 getinge became aware of an issue with one of surgical lights - volista access.It was stated that the power supply and battery pack were not properly grounded.The absence of grounding of the control box and the battery box did not present an immediate danger for patients or users because they did not have access to these boxes which are locked in a technical room.The parts accessible to users were well connected.The potential danger was therefore for a technician who works in the technical room because he would not be well protected in the event of an insulation fault in the power supply unit.This was unlikely to happen but remains a real risk if the protective earth was not correctly connected.External company mandated by the customer which regularly carries out checks of the electrical installations detected the problem and informed the customer.There was no injury reported, however, we decided to report the issue based on the potential of electrical shock to the technician working with that power supply.

• Brand Name: VOLISTA ACCESS
• 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: 18334423
• MDR Text Key: 330595301
• Report Number: 9710055-2023-00964
• Device Sequence Number: 1
• Product Code: FSY
• Combination Product (y/n): N
• Reporter Country Code: FR
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,User Facility,Company Representative
• Reporter Occupation: 505
• Type of Report: Initial
• Report Date: 12/15/2023

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: ARDVCS209018A
• Device Catalogue Number: ARDVCS209018A
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: 11/29/2023
• Initial Date FDA Received: 12/15/2023
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 04/05/2023
• Is the Device Single Use?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1