MAUDE Adverse Event Report: MEDTRONIC NAVIGATION, INC. O-ARM; IMAGE-INTENSIFIED FLUOROSCOPIC X-RAY

Device Problem Mechanical Problem (1384)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 01/08/2019

Event Type  malfunction  

Event Description

The o-arm did not work for case.The medtronic rep was contacted and recommended biomed in facility as they were not available.In-house biomed unable to fix.The procedure continued without o-arm.There was no harm to the patient.

• Brand Name: O-ARM
• Type of Device: IMAGE-INTENSIFIED FLUOROSCOPIC X-RAY
• Manufacturer (Section D): MEDTRONIC NAVIGATION, INC.; 300 foster street; littleton MA 01460
• MDR Report Key: 8343376
• MDR Text Key: 136272903
• Report Number: 8343376
• 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: Risk Manager
• Type of Report: Initial
• Report Date: 02/07/2019

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
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 02/07/2019
• Date Report to Manufacturer: 02/15/2019
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 02/15/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 23725 DA