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

Model Number BI70002000

Device Problems Computer Operating System Problem (2898); Adverse Event Without Identified Device or Use Problem (2993)

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

Event Date 06/28/2021

Event Type  malfunction  

Manufacturer Narrative

A medtronic representative went to the site to test the equipment.Testing found that the system was dropping in and out of stand alone mode.Multiple charger card errors were found.Multiple charger enclosure replacements were performed, but firmware failed.Successful replacement was done and it was found that battery tray 1 was not holding charge.Battery tray 1 was replaced.The fault was noted to have returned july 12th.There were 120 charger card errors observed.The umbilical cable was replaced and there were no further charger card errors.The system passed the system checkout and was found to be fully functional.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 was slow pass initialization during boot up.There was no patient present.

Manufacturer Narrative

Concomitant medical products: other relevant device(s) are: product: b i71000175 (kit svc o2 enclosure charger), lot# /s/n#: (b)(6).A hardware analysis was initiated to determine the probable cause of the issue.Analysis found the "slow initialization".Enclosure charger passed visual inspection and was installed in imaging system.The system did not initialized.Software firmware mismatch error.Imaging acquisition system firmware installer confirm, charger car 1 is no longer unable to hold firmware.Installed firmware.Was the following codes apply to the above product, fdm b01, fdr c02, fdc d02.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) continuation of d10: section d information references the main component of the system.Other relevant device(s) are: product (kit svc o2 bi71000175 enclosure charger: lot # 90121747) and (kit svc o2 bi71000163 tray asy 4 battery :lot# rev 5 : s/n na): (kit svc o2 bi71000175 enclosure charger:lot#50221003) a hardware analysis was initiated to determine the probable cause of the issue (kit svc o2 bi71000175 enclosure charger).Analysis was unable to confirm reported complaint."slow initalization." enclosure charger passed visual inspection and was installed in imaging system test system c1416.The system did not initialized.Motion, generator, communication and charging did not ready.Imaging acquisition system computer did not power on.For product (kit svc o2 bi71000163 tray asy 4 battery): a hardware analysis was initiated to determine the probable cause of the issue.Analysis unable to confirm reported issue "slow initalization." 4 batteries tray was tested by using fluke digital multimeter.Battery tray failed bench test due to 2 of the 4 batteries were measured between 8-9 vdc which are not within specs.A hardware analysis of bi71000175 enclosure charger: lot#50221003 was initiated to determine the probable cause of the issue.Analysis found "multiple charger card errors." enclosure charger passed visual inspection and was installed in imaging system.The system did not initialized.Firmware software mismatch issues.Image acquisition system firmware installer confirm older firmware version installed on charger cards.Unable to upgrade charger cards and backplane.Firmware installation failed.Heat build up of enclosure and chargers.The following codes apply to the above: fdm b01 fdr c02 fdc d02.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 45640 ; MX 45640
• MDR Report Key: 12185941
• MDR Text Key: 263615642
• Report Number: 3006544299-2021-00295
• Device Sequence Number: 1
• Product Code: OWB
• UDI-Device Identifier: 00763000355555
• UDI-Public: 00763000355555
• Combination Product (y/n): N
• PMA/PMN Number: K200074
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Type of Report: Initial,Followup,Followup
• Report Date: 08/23/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/16/2021
• 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
• Date Returned to Manufacturer: 07/29/2021
• Date Manufacturer Received: 08/05/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: SEE H10; SEE H10