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

Model Number BI70000028230

Device Problems Failure to Run on Battery (1466); Data Problem (3196)

Patient Problem No Patient Involvement (2645)

Event Date 05/24/2019

Event Type  malfunction  

Manufacturer Narrative

If information is provided in the future, a supplemental report will be issued.

Event Description

Medtronic received information from a user facility regarding an imaging system outside of a procedure.The caller indicated that the voltage monitor for the motion batteries was reading lower than the ifu recommended 9 bars at 2 minutes test.The motion batteries were replaced and the next step was to confirm the charger cards were operating at the correct voltage.There was no patient involved with this issue.

Manufacturer Narrative

Concomitant medical products: other relevant device(s) are: product id: bi71000125, serial/lot #: unknown; product id: bi30000148, serial/lot #: unknown; a medtronic representative went to the site to test the equipment.Hardware parts were replaced.A system checkout was performed and the system was working as intended.Evaluation codes that apply to this testing: 10, 114, 4315.No parts have been returned to the manufacturer for analysis.Device code c91397.Pertains to the svc kit bi71000125 8 pack battery kit.Device code c91397 pertains to the indicator bi30000148 battery monitor.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.

Event Description

Additional information was received.It was reported that the charger cards output voltage and battery voltage were confirmed to be within specification.The next step was to calibrate the new battery monitor board in accordance with the latest technical bulletin.It was noted that the cause was most likely a combination of batteries aging on the motion side of the system due to a marginally longer drive from the storage area to the most common theatres and the coincidental timing of the fca coming out while the preventative maintenance (pm) was due in only 3 months from the initial case date.The second item was the calibration of the battery monitor board being out of calibration when compared to the voltage displayed by the system board and the batteries themselves under load.

Manufacturer Narrative

H3: the battery monitor indicator was returned to the manufacturer for analysis.The battery monitor indicator was found to be fully functional with no problem found.The reported event could not be duplicated by medtronic personnel.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 3RD EDITION
• 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: 8649723
• MDR Text Key: 146362733
• Report Number: 3004785967-2019-00950
• Device Sequence Number: 1
• Product Code: OXO
• Combination Product (y/n): N
• PMA/PMN Number: K092564
• 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: 10/21/2019

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: BI70000028230
• Device Catalogue Number: BI70000028230
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/30/2019
• Initial Date Manufacturer Received: 05/24/2019
• Initial Date FDA Received: 05/29/2019
• Supplement Dates Manufacturer Received: 08/26/2019; 08/26/2019
• Supplement Dates FDA Received: 09/03/2019; 10/21/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1