MAUDE Adverse Event Report: SIEMENS ARDIS Q BIPLANE WITH PURE SOFTWARE; BIPLANE IMAGING

Device Problems No Display/Image (1183); Device Inoperable (1663); Application Program Problem (2880)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 01/07/2016

Event Type  malfunction  

Event Description

Siemens artis q biplane using pure software was being used in the neuro interventional suite.The software appears to have malfunctioned and one of the screens allowing visualization of the procedure by the provider unexpectedly went blank.It was by chance that the screen that went blank was a redundancy screen and no negative patient outcomes were experienced as a result of this malfunction.However, had the other plane screen been affected the provider would have lost all visualization of the procedure.This event is considered a near miss.Dates of use: installed (b)(6) 2015.Reason for use: radiographic biplane images used during interventional radiol.

• Brand Name: ARDIS Q BIPLANE WITH PURE SOFTWARE
• Type of Device: BIPLANE IMAGING
• Manufacturer (Section D): SIEMENS
• MDR Report Key: 5366125
• MDR Text Key: 36227288
• Report Number: MW5059291
• Device Sequence Number: 1
• Product Code: IZI
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 01/08/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/08/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 58 YR