MAUDE Adverse Event Report: MEDTRONIC NAVIGATION, INC (LITTLETON) O-ARM 1000 IMAGING SYSTEM 3RD EDITION; IMAGE-INTENSIFIED FLUOROSCOPIC X-RAY SYSTEM, M

Model Number BI70000028230

Device Problems Failure to Run on Battery (1466); Unexpected Shutdown (4019)

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

Event Date 09/08/2021

Event Type  malfunction  

Manufacturer Narrative

Device evaluated by mfr: a manufacturer rep went to the site to test the system.The system passed the system checkout after parts were replaced.Concomitant medical products: other relevant device(s) are: product id: b i31000478 ,product id: bi31000479, product id: bi71000524, product id: bi71000581, product id: bi71000126, product id: bi71000125, product id: bi71000514, product id: bi71000480.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 image acquisition system (ias) shut down automatically during post operative inspection. it was found that voltage of motor battery was low. also, it was reported that mvs sometimes restarted by itself. no patient injury was involved.

Manufacturer Narrative

H2: additional information: d10: bi71000480, lot no:s719100399; bi71000477, lotno:s1311ljx; bi71000486, lotno:s1248orc h3: the board and uninterruptible power supply (ups) were returned to the manufacturer for analysis.Analysis found that the reported issue could not be confirmed with either component.No failure was found while under testing.(b01, c19, d15) the motor battery charger board was returned to the manufacturer for analysis.Analysis found that the reported issue could not be confirmed; however, the board was electrically overstressed (b01, c02, 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: the mobile view station (mvs) power board (part: bi71000514, return part: bi71000514) was returned to the manufacturer for analysis.Analysis found that the board arrived with two missing fuses and it was not possible to test further.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 1000 IMAGING SYSTEM 3RD EDITION
• Type of Device: IMAGE-INTENSIFIED FLUOROSCOPIC X-RAY SYSTEM, M
• Manufacturer (Section D): MEDTRONIC NAVIGATION, INC (LITTLETON); 300 foster st; littleton MA 01460
• Manufacturer (Section G): MEDTRONIC NAVIGATION, INC (LITTLETON); 300 foster st; littleton MA 01460
• Manufacturer Contact: glen belmer ; 7000 central avenue ne rcw215; minneapolis, MN 55432 ; 6122713209
• MDR Report Key: 12460077
• MDR Text Key: 271033517
• Report Number: 3004785967-2021-01097
• Device Sequence Number: 1
• Product Code: OXO
• Combination Product (y/n): N
• Reporter Country Code: TH
• PMA/PMN Number: K092564
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 01/19/2022

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 Model Number: BI70000028230
• Device Catalogue Number: BI70000028230
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/23/2021
• Initial Date Manufacturer Received: 09/08/2021
• Initial Date FDA Received: 09/13/2021
• Supplement Dates Manufacturer Received: 12/01/2021; 12/23/2021
• Supplement Dates FDA Received: 12/02/2021; 01/19/2022
• Was Device Evaluated by Manufacturer?: Yes
• 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...."