VISTA BIS MONITOR

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-12-05 for VISTA BIS MONITOR manufactured by Medtronic, Inc..

Event Text Entries

[129319923] A bis vista monitor that was placed on top of an anesthesia machine in the operating room. The monitor sparked. We believe it was due to an internal short in the lithium battery of the unit. Recently medtronic has issued a statement that all bis vista lithium batteries over the age of four years are more prone to this happening. All of the batteries in use are near or at their four year age mark. It was decided back in august that once the new batteries arrived we would replace all that are over two years of age, however they have been on back order since then, with no hard arrival date as of yet. With the sparking issue that occurred today, it has been decided that all of the batteries should be removed from the monitors in the operating room and in out-of-operating room areas. These units will still function properly, as the battery is only there as a back up if the unit is unplugged. Monitors without batteries do need to be marked appropriately, to ensure that they stay plugged in while in use and we will label them accordingly. Manufacturer response for bis monitor, vista bis monitor (per site reporter). The rep from the company did come in today and checked out the unit. We both took pictures of the inside of the unit. We requested that the rep send out an engineer to do a more extensive evaluation of the unit. That evaluation has not occurred yet.
Patient Sequence No: 1, Text Type: D, B5

MAUDE Entry Details

• Report Number: 8132614
• MDR Report Key: 8132614
• Date Received: 2018-12-05
• Date of Report: 2018-11-28
• Date of Event: 2018-11-26
• Report Date: 2018-11-28
• Date Reported to FDA: 2018-11-28
• Date Reported to Mfgr: 2018-12-05
• Date Added to Maude: 2018-12-05
• Event Key: 0
• Report Source Code: User Facility report
• Manufacturer Link: N
• Number of Patients in Event: 0
• Adverse Event Flag: 0
• Product Problem Flag: 3
• Reprocessed and Reused Flag: 3
• Reporter Occupation: RISK MANAGER
• Health Professional: 3
• Initial Report to FDA: 3
• Report to FDA: 3
• Event Location: 3
• Single Use: 3
• Previous Use Code: 3
• Event Type: 3
• Type of Report: 3

Device Details

• Brand Name: VISTA BIS MONITOR
• Generic Name: FULL-MONTAGE STANDARD ELECTROENCEPHALOGRAPH
• Product Code: GWQ
• Date Received: 2018-12-05
• Device Availability: Y
• Device Age: 4 YR
• Device Eval'ed by Mfgr: *
• Device Sequence No: 1
• Device Event Key: 0
• Manufacturer: MEDTRONIC, INC.
• Manufacturer Address: 710 MEDTRONIC PARKWAY MINNEAPOLIS MN 554325604 US 554325604

Patients

Patient Number	Treatment	Outcome	Date
1	0		2018-12-05