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); Positioning Problem (3009)

Patient Problem No Patient Involvement (2645)

Event Date 08/05/2019

Event Type  malfunction  

Manufacturer Narrative

Onsite functional and visual examination was performed by a manufacturer representative.The representative aligned the rotor and adjusted the door switch, which resolved the issue.The system passed a system checkout and was returned to an operational condition.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 when un-crating, the system could not make gantry movements upon booting the system.The representative mentioned that the left side of the system had some mis-alignment.The crate that the system was transported in had no noticeable damage and the system did not look like it was damaged during shipping.

• 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: 8885822
• MDR Text Key: 172848088
• Report Number: 3006544299-2019-00174
• 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: Other
• Type of Report: Initial
• Report Date: 08/12/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/12/2019
• 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?: No
• Date Manufacturer Received: 08/05/2019
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/09/2019
• 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