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

Model Number 9733346

Device Problems Overheating of Device (1437); Smoking (1585)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 07/24/2019

Event Type  Injury  

Manufacturer Narrative

Patient information was unavailable at the time of report.Concomitant medical products: other relevant device(s) are: product id: bi31000172, serial/lot : unknown.A medtronic representative went to the site to test the equipment.It was reported that the issue could not be confirmed or replicated, no components were replaced.The system then passed the system checkout and was found to be fully functional.Another visit to the site was made by a medtronic representative and the pfc1000 board was replaced.The system passed the system checkout and was found to be fully functional.Device manufacturing date is unavailable.If information is provided in the future, a supplemental report will be issued.

Event Description

Medtronic received information regarding an imaging device being used for a cervical spine procedure.The issue occurred intraoperatively during the select patient/acquire scans and delayed the surgery by one hour or longer.It was reported that during the operation, the system got hot and smelled like smoke was coming out.The use of the imaging device was discontinued and the surgery was aborted.No further information was provided.

Manufacturer Narrative

If information is provided in the future, a supplemental report will be issued.

Event Description

Additional information received reported that there was no impact to patient outcome.

Manufacturer Narrative

Device evaluated by mfr: the pfc board was returned to the manufacture for evaluation.After functional testing and visual/physical examination the reported issue was confirmed.The bench tested the pfc board.They verified functionality of the pfc board, 380vdc output was measured, and fans function with 24vdc applied.No functional problem found.Visual inspection shows connector j2 broken/ damaged.Medtronic is submitting this report to comply with fda reporting regulations under 21 cfr parts 4 and 803.This report is based upon information obtained by medtronic, which the company may not have been able to fully investigate or verify prior to the date the report was required by the fda.Medtronic has made reasonable efforts to obtain more complete information and has provided as much relevant information as is available to the company as of the submission date of this report.This report does not constitute an admission or a conclusion by fda, medtronic, or its employees that the device, medtronic, or its employee caused or contributed to the event described in the report.In particular, this report does not constitute an admission by anyone that the product described in this report has any ¿defects¿ or has ¿malfunctioned¿.These words are included in the fda 3500a form and are fixed items for selection created by the fda to categorize the type of event solely for the purpose of regulatory reporting.Medtronic objects to the use of these words and others like them because of the lack of definition and the connotations implied by these terms.This statement should be included with any information or report disclosed to the public under the freedom of information act.

• 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 st; littleton MA 01460
• MDR Report Key: 8912368
• MDR Text Key: 154946444
• Report Number: 3004785967-2019-01487
• Device Sequence Number: 1
• Product Code: OXO
• Combination Product (y/n): N
• PMA/PMN Number: K050996
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional
• Type of Report: Initial,Followup,Followup
• Report Date: 04/23/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 9733346
• Device Catalogue Number: 9733346
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/13/2020
• Initial Date Manufacturer Received: 07/24/2019
• Initial Date FDA Received: 08/20/2019
• Supplement Dates Manufacturer Received: 09/05/2019; 04/20/2020
• Supplement Dates FDA Received: 09/30/2019; 04/23/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other