MAUDE Adverse Event Report: BARD ACCESS SYSTEMS INC SITE-RIGHT VISION II; SYSTEM, IMAGE PROCESSING, RADIOLOGICAL

Model Number 9770029

Device Problems Loss of Power (1475); Device Operates Differently Than Expected (2913)

Patient Problem Therapeutic Response, Increased (2272)

Event Date 06/02/2015

Event Type  malfunction  

• Brand Name: SITE-RIGHT VISION II
• Type of Device: SYSTEM, IMAGE PROCESSING, RADIOLOGICAL
• Manufacturer (Section D): BARD ACCESS SYSTEMS INC; 605 north 5600 west; salt lake city UT 84116
• MDR Report Key: 4959650
• Report Number: 4959650
• Device Sequence Number: 1
• Product Code: LLZ
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Type of Report: Initial
• Report Date: 07/06/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/07/2015
• Is this a Product Problem Report?: Yes
• Device Operator: Nurse
• Device Model Number: 9770029
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 07/07/2015
• Device Age: 1 YR
• Event Location: Hospital
• Date Report to Manufacturer: 08/03/2015
• Patient Sequence Number: 0