MAUDE Adverse Event Report: SANMINA -SCI SYSTEMS BASE SYS BI70002000 O-ARM SYS O2; INTERVENTIONAL FLUOROSCOPIC X-RAY SYSTEM

Model Number BI70002000

Device Problems Device Damaged Prior to Use (2284); Power Problem (3010); Application Program Freezes, Becomes Nonfunctional (4031)

Patient Problem No Patient Involvement (2645)

Event Date 01/15/2019

Event Type  malfunction  

Manufacturer Narrative

No patient information provided as no patient was involved in this concern.A medtronic representative visited the site and completed system checkout.Testing revealed that upon start up out of the shipping crate, the system pendant showed "not ready" status for the x-ray generator.The system failed 2d and 3d imaging modalities.It was found that the x-ray generator was not ready upon initial startup of system.Internal generator inspection revealed that there was no power to any of the generator components.The power conversion enclosure tested, and no 400vdc present at j2 pins 1 & 3.The power conversion enclosure was replaced per and system functionality was restored.The power conversion enclosure was returned to the manufacturer for analysis.Analysis found that there was no power going to the x-ray generator.The enclosure power conversion failed bench test and transistor q30 failed; it was shorted.Analysis found that the reported event was related to an electrical issue.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 a procedure.It was reported that there was no power going to the x-ray generator.This was found during a new install.There was no patient present when this issue was identified.

• Brand Name: BASE SYS BI70002000 O-ARM SYS O2
• Type of Device: INTERVENTIONAL FLUOROSCOPIC X-RAY SYSTEM
• Manufacturer (Section D): SANMINA -SCI SYSTEMS; km 15.5 no. 29, plant 06; carr. chapala-guadalajara,jal 45640 ; MX 45640
• Manufacturer (Section G): SANMINA -SCI SYSTEMS; km 15.5 no. 29, plant 06; carr. chapala-guadalajara,jal 45640 ; MX 45640
• Manufacturer Contact: stacy ruemping ; 7000 central avenue ne rcw215; minneapolis, MN 55432 ; 7635260594
• MDR Report Key: 8305939
• MDR Text Key: 135422453
• Report Number: 3006544299-2019-00028
• Device Sequence Number: 1
• Product Code: OWB
• UDI-Device Identifier: 00763000132378
• UDI-Public: 00763000132378
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K151000
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 02/05/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/05/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: BI70002000
• Device Catalogue Number: BI70002000
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/23/2019
• Date Manufacturer Received: 01/15/2019
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/18/2018
• 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