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

Model Number BI70002000

Device Problems Failure to Power Up (1476); Device Damaged Prior to Use (2284)

Patient Problem No Patient Involvement (2645)

Event Date 04/30/2019

Event Type  malfunction  

Manufacturer Narrative

No patient information provided as no patient was involved in this concern.) the manufacturer representative went to the site to test the imaging system.The reported issue was confirmed and the system would not power on.The power tray had a moving voltage that would go from 0vdc-50vdc and drift up and down between that.The battery charger enclosure also had illuminated s1 red.They were unable to boot the system.They replaced the battery charger enclosure and was able to intermittently, energize and de-energize the image acquisition system (ias).They took off the cover of the battery enclosure and was able to energize/de-energize utilizing s2 with no issues.Failure of user panel confirmed.The power conversion enclosure was returned to the manufacturer for evaluation.After visual/physical examination the reported issue was not confirmed.The part was returned unused.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 outside of a procedure that they were uncrating the system and were unable to power on the system.They connected the j cables internally and had the key turned and the dongle plugged in.Troubleshooting included when they pressed the button they have the batteries illuminated.No patient was present at the time of the event.

Manufacturer Narrative

A hardware analysis was initiated to determine the probable cause of the issue.Analysis found that casepart-285660 confirmed reported problem "the system was just booting up to the standalone mode." ias did not power on due to switch remaining in open state while on button was depressed.Faulty indicator panel.A hardware analysis was initiated to determine the probable cause of the issue.Analysis found that casepart-285515 was returned and they were unable to confirm reported complaint."while uncrating the system, they were unable to power on the system." installed ias power tray in o-arm system.The system readied.Motion, generator, communication and charging were successful.2d and 3d images were acquired.No problem found.A hardware analysis was initiated to determine the probable cause of the issue.Analysis found that casepart-285517 was returned and they were unable to confirm reported complaint."while uncrating the system, they were unable to power on the system." charger enclosure passed visual inspection.Installed in o-arm system.The system readied.Firmware was up to date.Motion calibration passed.2d and 3d images were acquired successfully.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: O2
• 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: 8636944
• MDR Text Key: 146081412
• Report Number: 3006544299-2019-00103
• Device Sequence Number: 1
• Product Code: OWB
• UDI-Device Identifier: 00763000132378
• UDI-Public: 00763000132378
• Combination Product (y/n): N
• PMA/PMN Number: K151000
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Type of Report: Initial,Followup
• Report Date: 06/27/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/23/2019
• 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?: Yes
• Date Returned to Manufacturer: 05/09/2019
• Date Manufacturer Received: 06/06/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1