MAUDE Adverse Event Report: MEDTRONIC NAVIGATION, INC (LITTLETON) O1; IMAGE-INTENSIFIED FLUOROSCOPIC X-RAY SYSTEM, MOBILE

Model Number BI70000028120

Device Problems Noise, Audible (3273); Application Program Freezes, Becomes Nonfunctional (4031)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 12/27/2019

Event Type  malfunction  

Manufacturer Narrative

Other relevant device(s) are: svc kit, bi71000579.Atp console etos kit svc, bi71000487.Pcba ht cntrlr kit svc, bi71000515.Pcba filament driver.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 the first spin was incomplete and terminated early.They were unable to take x-ray scout shots.They rebooted the system while around the patient and performed a successful spin.The system was brought back in for a confirmation spin and terminated early and then a loud popping noise from the gantry.There was a procedure delay of less than one hour and no impact to the patient.

Manufacturer Narrative

H3: the system was serviced in the field and failed imaging modalities tests, both in 2d and 3d, due to the system popping and the failure to take 2d imaged.It was found the system would only take one dark gray 2d image and not continuously take exposure when holding down the exposure button.The 3d spin worked mechanically but produced a static image.During the servicing it was found that the generator powered up as expected and that logs showered an "error 15, 17 and generator overload".The ht controller board was tested and had low voltage power supply.The tube did not have the filaments lit up as expected and the anode was not rotating.The ht controller board and filament driver board were replaced, which did not resolve the issue.It was found that the system took too long to discharge the high voltage capacitors, which were replaced on another case.The connection between the filament river board and the interface control board was tested and it was found the interface control board did not have the proper voltage.This was replaced in a separate case and it did not resolve the issue.The remote desktop was opened and they attempted rad exposure in 2dr mode which prompted a generator overload error.Troubleshooting was performed which showed an imbalance of kv between the tune and the hv tank.There was a short between the anode and cathode end of the tube.The tube was replaced and the filaments were then illuminated.The e009 generator was retested and overload troubleshooting steps were done which indicated the hv tank was not outputting correctly.The hv tank was replaced and the proper kv balance was restored.A kv loop, digital ma loop open and digital ma loop closed were performed and the dose output of the system as confirmed.The rad/gain calibrations were performed and the system failure was resolved.Codes 10, 120 and 4307 are applicable to this analysis.H3: analysis of the software logs determined that this was not a software issue.No failure was found.Codes 4112, 213 and 67 are ap applicable to this analysis.H2: additional information was received.See below for the lot numbers of relevant products.Pcba bi31000118 ht controller pcb, lot number: rev.3 : s/n(b)(6); svc kit bi71000579 atp console etos, lot number: rev.3 : s/n (b)(6); filament driver, lot number: rev.2 : s/n (b)(6).D10: devices have been returned for analysis, though analysis is not yet complete on the hardware.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

H2/h3/h6: an hv tank was returned and passed bench testing.The measured resistance between all test points on the tank passed.No failure was found.Codes 10, 213 and 67 are applicable.H2/h3/h6: an x-ray tube was returned and passed bench testing.The resistance of the small and the large filament were within range.No failure was found.Codes 10, 213 and 67 are applicable.H2/h3/h6: the filament driver was returned and analyzed.It was installed in a system, the system initialized.Motion, generator, co mmunication and charging readied.2d and 3d images were acquired successfully.No failure was found.Codes 10, 213 and 67 are applicable.H2/h3/h6: the controller was returned and analyzed.It was installed in a system and the system initialized.Motion, generator, communication and charging readied.2d and 3d images were acquired successfully.Codes 10, 213 and 67 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: O1
• 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: 9531714
• MDR Text Key: 179411543
• Report Number: 3004785967-2019-02205
• Device Sequence Number: 1
• Product Code: OXO
• UDI-Device Identifier: 00643169353428
• UDI-Public: 00643169353428
• Combination Product (y/n): N
• PMA/PMN Number: K092564
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Type of Report: Initial,Followup,Followup
• Report Date: 02/26/2020

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: Health Professional
• Device Model Number: BI70000028120
• Device Catalogue Number: BI70000028120
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/09/2020
• Initial Date Manufacturer Received: 12/27/2019
• Initial Date FDA Received: 12/30/2019
• Supplement Dates Manufacturer Received: 01/03/2020; 02/06/2020
• Supplement Dates FDA Received: 01/27/2020; 02/26/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: "SEE H10...."
• Patient Age: 72 YR