MAUDE Adverse Event Report: MEDTRONIC NAVIGATION, INC (LITTLETON) O-ARM 1000 IMAGING SYSTEM 3RD EDITION; IMAGE-INTENSIFIED FLUOROSCOPIC X-RAY SYSTEM, M

Model Number BI70000028120

Device Problem Application Program Freezes, Becomes Nonfunctional (4031)

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

Event Date 03/12/2024

Event Type  malfunction  

Manufacturer Narrative

Section d information references the main component of the system.Other relevant device(s) are: product id: bi71000475, product id: bi71000514r.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 being used outside of a procedure.It was reported that the system stayed on stand alone mode.They turned it on to bring it into the case and it would not get out of stand alone mode. there was no patient involvement. rebooted 3 -4 times with no change.

Manufacturer Narrative

Continuation of d10: section d information references the main component of the system.Other relevant device(s) are: product id: bi70000053, serial/lot #: unknown, product id: bi71000644, serial/lot #: unknown, product id: bi71000760, serial/lot #: unknown, product id: bi71000093, serial/lot #: unknown, product id: bi71000532, serial/lot #: unknown, product id: bi71000489, serial/lot #: unknown, product id: bi70000053, serial/lot #: unknown, product id: bi71000489, serial/lot #: unknown, product id: bi71000739, serial/lot #: unknown, product id: bi71000740, serial/lot #: unknown, product id: bi71000093, serial/lot #: unknown, product id: bi71000532, serial/lot #: unknown, product id: bi71000645, serial/lot #: unknown, product id: bi71000514, serial/lot #: unknown, product id: bi70000053, serial/lot #: unknown, product id: bi71000489, serial/lot #: unknown, product id: bi71000645, serial/lot #: unknown, product id: bi71000475, serial/lot #: unknown, product id: bi71000644, serial/lot #: unknown, product id: bi71000488, serial/lot #: unknown, product id: bi71000537, serial/lot #: unknown, product id: bi71000534, serial/lot #: unknown, product id: bi71000538, serial/lot #: unknown, product id: bi71000227, serial/lot #: unknown, product id: bi71000734, serial/lot #: unknown, product id: bi71000700, serial/lot #: unknown, product id: bi71000760, serial/lot #: unknown, product id: bi71000760, serial/lot #: unknown h2-3) a manufacturer representative (rep) went to the site to test the imaging system.Hardware, software, and instruments passed testing.Medtronic submits this report to comply with fda regulations 21 cfr parts 4 and 803.Medtronic has made reasonable efforts to provide 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.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.Medtronic will submit a supplemental report if additional relevant information becomes known.

Manufacturer Narrative

H3) onsite functional and visual examination was performed by a manufacturer representative.Multiple parts were replaced after a power surge.The mvs interface, both computers, pendant control, motion control, motion box rotor, motor box positioner.Functional testing determined that the mvs interface was functioning as designed.B01, c19, d14 functional testing determined that both computers, pendant control, motion control, motion box rotor, motor box positioner.B01, c07, c10, c02, d02 apply medtronic submits this report to comply with fda regulations 21 cfr parts 4 and 803.Medtronic has made reasonable efforts to provide 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.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.Medtronic will submit a supplemental report if additional relevant information becomes known.

Manufacturer Narrative

H2) device evaluation: d9 updated.H3, h6: the solid state relay was returned to the manufacturer for analysis.The solid state relay 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 mvs server was returned to the manufacturer for analysis.The mvs server 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 plr iport ethr was returned to the manufacturer for analysis.Analysis found that after the manufacturer representative installed the plr iport ethr into the imaging system the system did not initialized.The communication between mvs and the ias did not ready.Motion, generator and charging readied.Analysis found that the reported event was related to a electrical issue.B01, c02, d02 are applicable.Medtronic submits this report to comply with fda regulations 21 cfr parts 4 and 803.Medtronic has made reasonable efforts to provide 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.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.Medtronic will submit a supplemental report if additional relevant information becomes known.

Manufacturer Narrative

Device evaluation: h6: the ias computer was returned to the manufacturer for analysis.Analysis found that the ias computer failed bench test.Imaging system application failed to load with boot error messages.Analysis found that the reported event was related to a operating system issue.D18 are applicable.H6: the ias computer was returned to the manufacturer for analysis.Analysis found that the ias computer failed bench test.Bios failed.(time and date) failed.Analysis found that the reported event was related to a operating system issue.D18 are applicable.Medtronic submits this report to comply with fda regulations 21 cfr parts 4 and 803.Medtronic has made reasonable efforts to provide 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.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.Medtronic will submit a supplemental report if additional relevant information becomes known.

• Brand Name: O-ARM 1000 IMAGING SYSTEM 3RD EDITION
• Type of Device: IMAGE-INTENSIFIED FLUOROSCOPIC X-RAY SYSTEM, M
• Manufacturer (Section D): MEDTRONIC NAVIGATION, INC (LITTLETON); 300 foster st; littleton MA 01460
• Manufacturer (Section G): MEDTRONIC NAVIGATION, INC (LITTLETON); 300 foster st; littleton MA 01460
• Manufacturer Contact: glen belmer ; 7000 central avenue ne rcw215; minneapolis, MN 55432 ; 6122713209
• MDR Report Key: 18919254
• MDR Text Key: 337847005
• Report Number: 3004785967-2024-00174
• Device Sequence Number: 1
• Product Code: OXO
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K092564
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date: 05/24/2024

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: BI70000028120
• Device Catalogue Number: BI70000028120
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 03/12/2024
• Initial Date FDA Received: 03/17/2024
• Supplement Dates Manufacturer Received: 03/18/2024; 04/04/2024; Not provided; 05/01/2024
• Supplement Dates FDA Received: 04/02/2024; 05/01/2024; 05/23/2024; 05/24/2024
• 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