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

Model Number BI70002000

Device Problems Premature Discharge of Battery (1057); Smoking (1585); Use of Device Problem (1670)

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

Event Date 11/29/2023

Event Type  malfunction  

Manufacturer Narrative

Continuation of d10: section d information references the main component of the system.Other relevant device(s) are: product id: bi71000163r, serial/lot #: -, ubd: , udi#: ; product id: bi71000163r, serial/lot #: -, ubd: , udi#: ; product id: bi71000163r, serial/lot #: -, ubd: , udi#: ; product id: bi71000163r, serial/lot #: -, ubd: , udi#: ; product id: bi71000163r, serial/lot #: -, ubd: , udi#: ; product id: bi71000163r, serial/lot #: -, ubd: , udi#: ; product id: bi71000860r, serial/lot #: -, ubd: , udi#: ; product id: bi71000861r, serial/lot #: -, ubd: , udi#: ; product id: bi71000163r, serial/lot #: -, ubd: , udi#: ; product id: bi71000162r, serial/lot #: -, ubd: , udi#: h3, h6: a medtronic representative went to the site to test the equipment.Testing revealed that the manufacturer representative con firmed the system was left unplugged for an unknown extended period of time.Initially tried force charging the system.The force charge initially took, however, the next morning upon boot up the system quickly lost power and began to smell like burning.More extensive troubleshooting was performed and it was found that the power conversion had a fault and that the battery stack had failed to hold charge.The manufacturer representative returned to site with a new set of batteries, a power conversion enclosure and an updated power tray.Once the batteries were replaced, power conversion was replaced and power tray were replaced the system was once again able to take charge and shoot x-ray in 2d and 3d modes.The imaging system then passed the system checkout and was found to be fully functional.B01, c02, d02 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.

Event Description

Medtronic received information regarding an imaging system being used outside of a procedure.It was reported that the outlet the unit was plugged into was not outputting power, which caused the system to become inoperable due to drained batteries. there was no patient involvement.Additional information was received.The wall outlet had no voltage present.

Manufacturer Narrative

H2) device evaluation: d9 updated.H3, h6: the power tray was returned to the manufacturer for analysis.The power tray 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.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: continuation of d10: section d information references the main component of the system.Other relevant device(s) are: product id: bi71000176, serial/lot #: (b)(6), serial/lot#: (b)(6).The power conversion enclosure was returned to the manufacturer for evaluation.After functional testing and visual/physical examination, the reported issue was confirmed.The results of the analysis concluded that both transistors were shorted causing the batteries to drain.Codes: b01, c02, d02 the image acquisition system (ias) power tray was received by the manufacturer and was pending analysis.Codes: b21, c21, d16.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
• Manufacturer (Section G): SANMINA -SCI SYSTEMS; km 15.5 no. 29, plant 06; carr. chapala-guadalajara,jal 45640 ; MX 45640
• Manufacturer Contact: glen belmer ; 7000 central avenue ne rcw215; minneapolis, MN 55432 ; 6122713209
• MDR Report Key: 18323386
• MDR Text Key: 330573584
• Report Number: 3006544299-2023-00823
• Device Sequence Number: 1
• Product Code: OWB
• UDI-Device Identifier: 00763000132378
• UDI-Public: 00763000132378
• 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: Biomedical Engineer
• Type of Report: Initial,Followup
• Report Date: 03/06/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/13/2023
• 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
• Date Manufacturer Received: 02/16/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/18/2019
• 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
• Treatment: "SEE H10...."