MAUDE Adverse Event Report: MEDTRONIC NAVIGATION, INC.; SYSTEM, X-RAY, FLUROSCOPIC, IMAGE-INTENSIFIED

Model Number PAXSCAN4030D/SHFRM300

Device Problems Operating System Becomes Nonfunctional (2996); Output Problem (3005); Problem with Software Installation (3013)

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

Event Date 03/22/2021

Event Type  malfunction  

Event Description

O-arm not functioning properly when case was being set up.Sales rep was updating system when it ended up crashing and they had to call their tech in to correct it issue.This was a software issue.Case had to be rescheduled.

• Type of Device: SYSTEM, X-RAY, FLUROSCOPIC, IMAGE-INTENSIFIED
• Manufacturer (Section D): MEDTRONIC NAVIGATION, INC.; 826 coal creek cir; louisville CO 80027
• MDR Report Key: 11737027
• MDR Text Key: 247696220
• Report Number: 11737027
• Device Sequence Number: 1
• Product Code: OXO
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 04/14/2021

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 Operator: No Information
• Device Model Number: PAXSCAN4030D/SHFRM300
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 04/14/2021
• Device Age: 3 YR
• Event Location: Hospital
• Date Report to Manufacturer: 04/28/2021
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 04/28/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Age: 23360 DA
• Patient Weight: 102