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

Model Number ARDVST229013A

Device Problem Fluid/Blood Leak (1250)

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

Event Date 02/14/2024

Event Type  malfunction  

Manufacturer Narrative

Additional information will be provided following the conclusion of the investigation.E1b event site name: (b)(6); h3 other text : device not returned to manufacturer.

Event Description

On 14th february 2024, getinge became aware of an issue with one of our surgical lights ¿ volista standop 400/400.As it was stated, the water was present inside the device.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 in case of reoccurrence.

• 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: 18720060
• MDR Text Key: 335554364
• Report Number: 9710055-2024-00154
• Device Sequence Number: 1
• Product Code: FSY
• Combination Product (y/n): N
• Reporter Country Code: PL
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,User Facility,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 02/16/2024

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: ARDVST229013A
• Device Catalogue Number: ARDVST229013A
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: 02/14/2024
• Initial Date FDA Received: 02/16/2024
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 11/15/2019
• Is the Device Single Use?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1