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

Model Number BI-700-00027-120

Device Problems Device Operates Differently Than Expected (2913); Appropriate Term/Code Not Available (3191)

Patient Problem No Patient Involvement (2645)

Event Date 07/24/2014

Event Type  malfunction  

Event Description

A medtronic representative received a report from a site that when pressing the drive handle to move their imaging system forward, it drove backward.In trouble-shooting, the site released the clutch and manually moved the system.No further details were provided.There was no patient present when this issue was identified.

Manufacturer Narrative

No patient information provided as no patient was involved in this concern.A medtronic representative, following-up, has not been allowed on site to perform a system check-out as the hospital is still under construction.No parts have been returned to manufacturer for analysis.

Manufacturer Narrative

The suspect strength gauge was returned for evaluation.The reported event was confirmed.Strength gauge was tested on the bench, when strength was applied to the gauge, output was constant not changing as expected.Replacing the strength gauge resolved the issue.

Manufacturer Narrative

A medtronic field representative went onsite and found that the strain gauge was broken on the system.The representative replaced the strain gauge and this resolved the issue.System is no fully functional.

Manufacturer Narrative

(b)(4).On mdr-fu1 was missing a "w." it should state, "system is now fully functional.".

• Brand Name: O-ARM 1000 IMAGING SYSTEM
• Type of Device: IMAGE-INTENSIFIED FLUOROSCOPIC X-RAY SYSTEM, MOBILE
• Manufacturer (Section D): MEDTRONIC NAVIGATION, INC. (LITTLETON); 300 foster street; littleton MA 01460
• Manufacturer (Section G): MEDTRONIC NAVIGATION, INC.; 826 coal creek circle; louisville CO 80027 9710
• Manufacturer Contact: amos jarrette ; 826 coal creek circle; louisville, CO 80027-9710 ; 7208902082
• MDR Report Key: 4030243
• MDR Text Key: 4728096
• Report Number: 1723170-2014-00884
• Device Sequence Number: 1
• Product Code: OXO
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K050996
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Company Representative,company representati
• Reporter Occupation: Medical Equipment Company Technician/Representative
• Type of Report: Initial,Followup,Followup
• Report Date: 08/24/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/22/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: BI-700-00027-120
• Device Catalogue Number: 9732719
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/05/2014
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 07/30/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/27/2014
• 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