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

Model Number BI70002000

Device Problems Use of Device Problem (1670); Adverse Event Without Identified Device or Use Problem (2993); Application Program Freezes, Becomes Nonfunctional (4031)

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

Event Date 06/13/2022

Event Type  malfunction  

Event Description

Medtronic received information regarding an imaging system being used during a spinal procedure.It was reported that the system's image acquisition system (ias) was stuck in the "waiting to initialize" screen.The system was already in a turned-on state and a spine hd spin had been performed prior to the event.When the gantry was opened, the system was brought around the patient and the gantry was closed then the 'waiting to initialize' screen popped up.The site rebooted the system five times and the screen showed two red x's, one was in the middle by the 'disabled' button and the other one was on the top by the gears.It was noted that this system had taken very long to initialize in the past and a previous solution was to leave the system shut off for an extended amount of time.There was no impact on patient outcome and the issue caused a delay of less than 1 hour.Some troubleshooting was done to try and resolve the issue, the umbilical cord was disconnected and both systems were shut down and rebooted.Mobile view station (mvs) and ias were booted individually but the error message still remained on the ias screen.

Manufacturer Narrative

Concomitant medical products: other relevant device(s) are: product id: bi71000225r.Device evaluated by mfr: no products have been returned to medtronic for analysis.(b)(4).If information is provided in the future, a supplemental report will be issued.

Manufacturer Narrative

H3.The system was serviced in the field, and the x-ray status on the pendant would not initialize.Generator would not power on.Fuses isolated standalone board were bad.Isolated standalone board had no power.The isolated standalone board and fuses were replaced.The system passed all testing.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: a hardware analysis was initiated to determine the probable cause of the reported behavior.Analysis found that the complaint was not verified.There was no failure found and the unit performed as intended.Codes b01 is applicable and previously reported.Codes 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.

• 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: 14713298
• MDR Text Key: 294578050
• Report Number: 3006544299-2022-00213
• Device Sequence Number: 1
• Product Code: OWB
• UDI-Device Identifier: 00763000542849
• UDI-Public: 00763000542849
• 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
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 09/19/2022

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?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 06/13/2022
• Initial Date FDA Received: 06/16/2022
• Supplement Dates Manufacturer Received: 06/16/2022; 08/30/2022
• Supplement Dates FDA Received: 07/05/2022; 09/19/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/23/2022
• 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...."
• Patient Age: 75 YR
• Patient Sex: Female
• Patient Weight: 42 KG