MAUDE Adverse Event Report: SANMINA -SCI SYSTEMS O-ARM O2 IMAGING SYSTEM; INTERVENTIONAL FLUOROSCOPIC X-RAY SYSTEM

Model Number BI70002000

Device Problems Adverse Event Without Identified Device or Use Problem (2993); Unexpected Shutdown (4019); Application Program Freezes, Becomes Nonfunctional (4031)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 02/18/2023

Event Type  malfunction  

Manufacturer Narrative

A manufacturer representative went to the site to service the system.Replaced mvs power board, ups on/off cable to mvs power board, mvs interface cable and system board.Upgraded firmware and calibrated system board.Performed system checkout, o-arm is operational.The power board was returned for evaluation, however analysis was not yet complete at the time of this report.A follow up report will be sent when analysis is complete.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.

Event Description

Medtronic received information regarding an imaging system used in a sacroiliac and thoracolumbar procedure.It was reported that the system had flickering of the mobile viewing station (mvs) monitor.No impact on patient outcome.It was also reported that during equipment setup, the system was unable to expose and was unable to connect.The healthcare provider (hcp) was unsure if by connect, he meant mobile view station (mvs) to image acquisition system (ias).The use of medtronic imaging was aborted and the surgery continued.The probable cause was the ias no fully initializing.There was no impact to patient outcome.The biomed that called in the case was confused on the issue that the clinical rep reported to him.The issue that is happening is that the mvs power board is shutting off and then powering off the monitor (intermittent monitor that was reported) and then turning off the mvs computer.Since the mvs computer is turning off, the ias no longer is communicating with the mvs, which is why it cannot expose / connect.

Manufacturer Narrative

H2) device evaluation: d9 updated.H3, h6 = the mobile viewing system (mvs) cable was returned to the manufacturer for analysis.The mvs cable was found to be fully fu nctional with no problem found.The reported event could not be duplicated by medtronic personnel.B01, c19, d14 are applicable.H2) additional information: b5 updated.Additional codes = imf code f1908 added.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.

Event Description

Additional information was received.There was a surgical delay of ten minutes.

Manufacturer Narrative

H2) corrections of initial 2 submitted mdrs: d9: updated.Fdd/annex a codes for concomitant products have been updated.Continuation of d10 (updated): section d information references the main component of the system.Other relevant device(s) are: product id: bi71000823r, serial/lot #: (b)(6) rev.C, ubd: , udi#: ; product id: bi71000181, serial/lot #: (b)(6) rev.H, ubd: , udi#: ; product id: bi71000319, serial/lot #: -, ubd: , udi#: ; product id: bi71000916, serial/lot #: (b)(6) rev.C, ubd: , udi#: ; product id: bi71000181, serial/lot #: unknown, ubd: , udi#: ; product id: bi71000183r, serial/lot #: (b)(6) rev.13, ubd: , udi#: ; product id: bi71000167, serial/lot #: (b)(6) rev.2, ubd: , udi#: ; h3, h6: no parts have been returned to medtronic for analysis for products with the id = bi71000181 (lot number: unknown) and bi71000319.B17, c20, d15 are applicable.H3, h6: parts have been returned to medtronic for analysis, but analysis is pending completion.This applicable for products with the id = bi71000181 (lot number: 052022254 rev.H), bi71000823r, bi71000181 (lot number: 062160514 rev.H), bi71000916, and bi71000183r.B21, c21, d16 are applicable.Additional codes: img/annex g codes g02004, g02007, g02027, g02034 updated.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

H2, correction: d3 corrected.H3: the mvs power board was returned to the manufacturer for analysis.Analysis found that the mobile view station (mvs) power board passed the bench test.Fuses f10 and f11 passed the continuity test.The mvs power board was installed into a test system, and the mvs and ias did not power on.Analysis found that the reported event was related to an electrical issue.H6: fdm b01, fdr c02, and fdc d02 are applicable to the hardware 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.

Manufacturer Narrative

H2) device evaluation: h3, h6: the system control plate was returned to the manufacturer for analysis.Analysis found that the system control plate was installed into a test imaging system.The system did not initialize.The generator did not ready.The mobile viewing system (mvs) intermittently shut down.Analysis found that the reported event was related to a electrical issue.B01, c02, d02 are applicable.H3, h6: the mvs power board was returned to the manufacturer for analysis.The mvs power board was found to be fully functional with no problem found.The reported event could not be duplicated by medtronic personnel.B01, c19, d14 are applicable.H3, h6: the cable assembly was returned to the manufacturer for analysis.The cable assembly was found to be fully functional with no problem found.The reported event could not be duplicated by medtronic personnel.B01, c19, d14 are applicable.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

H3, h6: the mvs sever, lot number: 2434350 rev.C, was returned to the manufacturer for analysis.The part was found to be fully functional with no problem found.The reported event could not be duplicated by medtronic personnel.Codes b01, c19, and d14 are applicable to this 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 O2 IMAGING SYSTEM
• Type of Device: INTERVENTIONAL FLUOROSCOPIC X-RAY SYSTEM
• Manufacturer (Section D): SANMINA -SCI SYSTEMS; km 15.5 no. 29, plant 06; carr. chapala-guadalajara,jal MA 45640 ; MX 45640
• Manufacturer (Section G): SANMINA -SCI SYSTEMS; km 15.5 no. 29, plant 06; carr. chapala-guadalajara,jal MA 45640 ; MX 45640
• Manufacturer Contact: glen belmer ; 7000 central avenue ne rcw215; minneapolis, MN 55432 ; 6122713209
• MDR Report Key: 16575654
• MDR Text Key: 311823250
• Report Number: 3004785967-2023-00160
• Device Sequence Number: 1
• Product Code: OWB
• UDI-Device Identifier: 00763000355555
• UDI-Public: 00763000355555
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K200074
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date: 07/13/2023

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: BI70002000
• Device Catalogue Number: BI70002000
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 02/20/2023
• Initial Date FDA Received: 03/20/2023
• Supplement Dates Manufacturer Received: 04/03/2023; 04/21/2023; 05/09/2023; 05/23/2023; 06/27/2023
• Supplement Dates FDA Received: 04/21/2023; 04/26/2023; 05/15/2023; 06/01/2023; 07/13/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/09/2021
• 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