MAUDE Adverse Event Report: MEDTRONIC NAVIGATION, INC (LITTLETON) O-ARM 1000; IMAGE-INTENSIFIED FLUOROSCOPIC X-RAY SYSTEM, MOBILE

Model Number 9732719

Device Problems Component Missing (2306); Physical Resistance/Sticking (4012)

Patient Problem No Patient Involvement (2645)

Event Date 05/06/2019

Event Type  malfunction  

Manufacturer Narrative

No patient information provided as no patient was involved in this concern.Unique identifier not available at the time of reporting.The manufacturer representative went to the site to test the navigation system.The reported issue was confirmed and the power cord was replaced.A completed system checkout was performed and the system is fully functional.The power cable was returned to the manufacture for evaluation.After functional testing, performance testing and visual/physical examination the reported issue was confirmed.Visual inspection notes that the molded plug surrounding area for the black conductor has been subject to electrical over-stress.The blade is missing.Continuity testing finds the white conductor and the ground conductor are functional.The black conductor has an open.They observed damage to the power cable.Manufacturer date not available at the time of reporting.If information is provided in the future, a supplemental report will be issued.

Event Description

Medtronic received information regarding an imaging system.It was reported outside of a procedure that the ground prong was broken off of the power cord.No patient was present at the time of the event.

• Brand Name: O-ARM 1000
• Type of Device: IMAGE-INTENSIFIED FLUOROSCOPIC X-RAY SYSTEM, MOBILE
• Manufacturer (Section D): MEDTRONIC NAVIGATION, INC (LITTLETON); 300 fosters st; littleton,ma 01460
• Manufacturer (Section G): MEDTRONIC NAVIGATION, INC (LITTLETON); 300 fosters st; littleton,ma 01460
• Manufacturer Contact: stacy ruemping ; 7000 central avenue ne rcw215; minneapolis, MN 55432 ; 7635260594
• MDR Report Key: 8675798
• MDR Text Key: 147233185
• Report Number: 3004785967-2019-01003
• Device Sequence Number: 1
• Product Code: OXO
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K050996
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,user f
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 06/06/2019

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: Health Professional
• Device Model Number: 9732719
• Device Catalogue Number: 9732719
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/16/2019
• Initial Date Manufacturer Received: 05/21/2019
• Initial Date FDA Received: 06/06/2019
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1