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

Model Number BI70000027100

Device Problems Failure to Charge (1085); Overheating of Device (1437); Smoking (1585); Communication or Transmission Problem (2896)

Patient Problem No Patient Involvement (2645)

Event Date 08/15/2019

Event Type  malfunction  

Manufacturer Narrative

No patient information provided as no patient was involved in this concern.Foreign country: (b)(6).No parts have been received by the manufacturer for evaluation.(b)(4).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 when the system was being stored in the storage place, oil leaked from the bottom of the image acquisition system (ias) and there was an unusual odor.Update from the site stating that the battery was burned and the battery liquid leaked.There was also an issue between the image acquisition system (ias) and the mobile view station (mvs) they were not communicating.After the communication issue was resolved there was an issue with the mvs not being able to be charged.No patient was present at the time of the event.

Manufacturer Narrative

Correction made to the event description.The manufacturer representative went to the site to test the imaging system.The reported issue was confirmed and parts were replaced.Eval code method 10 is associated with this analysis.Eval code result 114 is associated with this analysis.Eval code conclusion 4307 is associated with this analysis.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

Update from the sight regarding the leakage of oil and unusual odor, the oil did not leak.The battery was burned and the battery liquid leaked.Therefore, the unusual odor occurred.Replacement of the motion and x-ray battery was performed.Also, the umbilical cable was replaced because the image acquisition system (ias) could not communicate with the mobile viewing station (mvs).After replacement, charging became unable to be performed due to anomaly of the mvs power board, so replacement of the mvs power board was performed.At the same time, the software was upgraded.Normal operation was confirmed and it was completed.

Manufacturer Narrative

An mvs power board assembly was returned to medtronic for analysis.Analysis revealed that the power board passed visual inspection, but when installed in a test system, the system did not power on.An electrical failure was confirmed.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
• 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: 8960828
• MDR Text Key: 156456459
• Report Number: 3004785967-2019-01558
• 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: 05/06/2020

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: 04/27/2020
• Initial Date Manufacturer Received: 08/15/2019
• Initial Date FDA Received: 09/04/2019
• Supplement Dates Manufacturer Received: 09/23/2019; 05/04/2020
• Supplement Dates FDA Received: 09/24/2019; 05/06/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1