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

Model Number BI70000027100

Device Problem Application Program Freezes, Becomes Nonfunctional (4031)

Patient Problems No Known Impact Or Consequence To Patient (2692); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 10/21/2020

Event Type  malfunction  

Manufacturer Narrative

The system was serviced in the field and passed all tests.Hardware parts were replaced.Concomitant medical products: other relevant device(s) are: product id: bi70000052, lot #: unknown.If information is provided in the future, a supplemental report will be issued.

Event Description

Medtronic received information regarding an imaging system used during a sacroiliac and thoracolumbar procedure.It was reported that after the images were taken, when looking at the image acquisition system (ias), the screen of the system was a 3-bar display that was displayed at startup.The issue was resolved after rebooting.There was no delay and no impact to the patient.Additional information was noted that the image acquisition system's monitor showed three lines/bars on the screen which is what it is like when it is starting up.The three bars were displayed when the hospital staff saw the monitor after taking an image with the imaging system.The imaging system was rebooted after the hospital staff noticed the three bars being displayed.However, it was not reported that the screen was frozen while displaying the three bars.The system and image acquisition system could still function after the rebooting.

Manufacturer Narrative

H2: additional information.Ime and imf codes have been added.It was confirmed only product id: bi70000052 was replaced.Replacement was previously reported in the system service noted in the initial regulatory report.H2: correction - in the initial regulatory report it was noted that codes codes 10, 120 and 4307 were applicable, however fdc code 114 was reported in h6 instead of 120.H6 updated to reflect fdc code 120 (c02).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: the panel assembly indicator was returned to the manufacturer for analysis.The device was installed in a test system.On/off switch is functional, and emergency button is also functional, and all leds is lit.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.

• Brand Name: O-ARM 1000 IMAGING SYSTEM
• Type of Device: IMAGE-INTENSIFIED FLUOROSCOPIC X-RAY SYSTEM, MOBILE
• Manufacturer (Section D): MEDTRONIC NAVIGATION, INC (LITTLETON); 300 foster st; littleton MA 01460
• MDR Report Key: 10818219
• MDR Text Key: 215958487
• Report Number: 3004785967-2020-01350
• Device Sequence Number: 1
• Product Code: OXO
• Combination Product (y/n): N
• PMA/PMN Number: K050996
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup,Followup
• Report Date: 02/16/2021

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: No Information
• Device Model Number: BI70000027100
• Device Catalogue Number: BI70000027100
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/15/2021
• Initial Date Manufacturer Received: 10/21/2020
• Initial Date FDA Received: 11/10/2020
• Supplement Dates Manufacturer Received: 01/04/2021; 02/12/2021
• Supplement Dates FDA Received: 01/13/2021; 02/16/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1