MAUDE Adverse Event Report: MAQUET SAS VOLISTA; LAMP, SURGICAL

Model Number VST44SF

Device Problem Loss of Power (1475)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 11/03/2015

Event Type  malfunction  

Manufacturer Narrative

On (b)(6) 2015 12:49 pm (gmt-5:00) added by (b)(6): a maquet technician evaluated the device and found a broken can-bus cable in the power supply.He replaced the power supply with a new one and returned the device to service.The investigation is on-going and the results will be included in a follow up report.

Event Description

The customer reported that both cupolas switched off during a surgical case.No injuries were reported.(b)(4).

Manufacturer Narrative

(b)(4).Maquet determines that the power supply was not connected to a backup system.Due to the absence of a connection to a 24v backup circuit, the system was not able to switch to an external backup system when a failure occurred at the mains power.The maquet field service technician verified that the device was functional ; however, the customer assessed that a connection of the light system to a backup 24v circuit was still not necessary.In order to comply with the iec (b)(4) standard (particular requirements for the safety of surgical luminaires and luminaires for diagnosis), the maquet portfolio includes several models of devices and power supplies: either equipped with a backup system, for major surgical lights that must comply with the "fail safe" requirement of the standard; or without integrated backup system, in case it is not a requirement of the standard (minor surgical luminaire, or luminaire for diagnosis).

Event Description

(b)(4).The customer reported that both cupolas of a surgical light system switched off during a surgical case, and switched on again automatically after a few minutes.No injuries were reported.(b)(4).

• Brand Name: VOLISTA
• Type of Device: LAMP, SURGICAL
• Manufacturer (Section D): MAQUET SAS; orléans cedex 2 ; FR
• Manufacturer (Section G): MARIE-FRANÇOISE CABEL - MAQUET SAS; parc de limère; avenue de la pomme de pi; orléans cedex 2 45074 ; FR 45074
• Manufacturer Contact: parc de limère; avenue de la pomme de pi; orléans cedex 2 45074
• MDR Report Key: 5262069
• MDR Text Key: 32751400
• Report Number: 9710055-2015-01034
• Device Sequence Number: 1
• Product Code: FTD
• Combination Product (y/n): N
• Reporter Country Code: AU
• PMA/PMN Number: KI130513
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Biomedical Engineer
• Type of Report: Initial,Followup
• Report Date: 02/11/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/02/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: VST44SF
• Device Catalogue Number: STP229002
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/03/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/01/2014
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1