MAUDE Adverse Event Report: MEDTRONIC NAVIGATION, INC (LITTLETON) BASE OARM BI70000028120 SYS 120V; IMAGE-INTENSIFIED FLUOROSCOPIC X-RAY SYSTEM, MOBILE

Model Number BI70000028120

Device Problems Component Missing (2306); Failure to Align (2522); Material Deformation (2976); Physical Resistance/Sticking (4012)

Patient Problem No Patient Involvement (2645)

Event Date 03/30/2019

Event Type  malfunction  

Manufacturer Narrative

A medtronic representative went to the site to test the equipment for a product maintenance test.The representative confirmed the system was not operating as intended.No parts were replaced at the time.If information is provided in the future, a supplemental report will be issued.

Event Description

Medtronic received information regarding an imaging device being used outside of a procedure.It was reported that a medtronic representative was performing a planned maintenance (pm) on the system and discovered that several parts needed to be replaced.There were a couple of damaged covers including a lower inner cover, lower door cap, two side covers, an x-stage cover, and a louver cover.The bulkhead/network cable was damaged.The bellows felt was missing.The pendant buttons were functioning but were worn and needed to be replaced as a preventive measure.The power cord was damaged.Additionally,the pm failed due to the coronal laser output being outside of specification.It was recommended that all the previously mentioned parts be replaced to bring the system up to manufacturer standards.There was no patient involvement.

Manufacturer Narrative

Device evaluation: a medtronic representative (rep) tested and serviced the equipment.The following parts were installed: bellows felt, x-stage cover, lower door cover, and coronal laser.The laser alignment and output tests then passed.It was stated that this servicing corrected any failure discrepancies that were found during the annual planned maintenance (pm).It was also noted that an inner cover was found to be damaged at install.The imaging system passed the system checkout and was performing as intended.Device evaluation: the pendant was returned to medtronic for further evaluation and the reported problem was confirmed.The pendant control failed visual inspection.The lamination on many of the pendant buttons were noted to have cracks.It was determined that there was a mechanical failure with the pendant related to wear.Device evaluation: the laser kit was returned to medtronic for further evaluation, and the reported problem was confirmed.It was noted that only the coronal laser was used; both sagittal lasers were unused and were within expected range.The coronal laser output measured 3.028 mw and exceeded the expected maximum output of 3.02mw.It was determined there was an electrical failure with the returned coronal laser.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 manufacturer representative went to the site to the site to test the imaging system.The reported issue was confirmed and the all of the final parts were installed from the planned maintenance (pm).Two new side covers, a lower inner cover, a new network junctions cable and a new power cable and a new front tube cover was also installed.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: BASE OARM BI70000028120 SYS 120V
• 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: 8555733
• MDR Text Key: 143263316
• Report Number: 3004785967-2019-00776
• 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: company representative
• Type of Report: Initial,Followup,Followup
• Report Date: 07/10/2019

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: Health Professional
• Device Model Number: BI70000028120
• Device Catalogue Number: BI70000028120
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/06/2019
• Initial Date Manufacturer Received: 03/30/2019
• Initial Date FDA Received: 04/26/2019
• Supplement Dates Manufacturer Received: 05/28/2019; 07/09/2019
• Supplement Dates FDA Received: 06/24/2019; 07/10/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1