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

Model Number BI70000027120

Device Problems Failure to Power Up (1476); Problem with Software Installation (3013)

Patient Problem No Patient Involvement (2645)

Event Date 05/28/2020

Event Type  malfunction  

Manufacturer Narrative

Other relevant device(s) are: kit svc bi710 00850 oarm comp 554/3.1.7 ) not available on the date of filing.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 that the system was down, it would not power up.There was no patient present.A manufacturer representative stated that the imaging system application had crashed and he was unable to upload new software.

Manufacturer Narrative

H3: a medtronic representative went to the site to test the equipment.Testing revealed that o-arm stuck in "system booting please wait" and o-arm computer found to be corrupted.The o-arm computer was replaced and the system tested with satisfactory results.The customer notified of "b" rated door cable findings, and needed to have door winch assy replaced.Fdm 10, fdr 114 and fdc 4307.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.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.A good faith effort will be made to obtain the applicable information relevant to the report.If information is provided in the future, a supplemental report will be issued.

Manufacturer Narrative

Continuation of d11: section d information references the main component of the system.Other relevant device(s) are: product id: winch assy bi70000161 door, serial/lot #: rev.4 : s/n (b)(6) h3, h6: the winch assembly was returned to medtronic for analysis.Testing was conducted and the issue was confirmed.Visual inspection shows cable strands were fraying from wear.Fdm 10, fdr 180, and fdc 4307 are applicable to the winch analysis.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.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.A good faith effort will be made to obtain the applicable information relevant to the report.If information is provided in the future, a supplemental report will be issued.

• 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: 10104607
• MDR Text Key: 193073626
• Report Number: 3004785967-2020-00606
• Device Sequence Number: 1
• Product Code: OXO
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,user f
• Type of Report: Initial,Followup,Followup
• Report Date: 07/02/2020

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: BI70000027120
• Device Catalogue Number: BI70000027120
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/26/2020
• Initial Date Manufacturer Received: 05/28/2020
• Initial Date FDA Received: 06/01/2020
• Supplement Dates Manufacturer Received: 06/01/2020; 06/29/2020
• Supplement Dates FDA Received: 06/16/2020; 07/02/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: "SEE H10...."; SEE H10...