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

Model Number BI70002000

Device Problems Failure to Power Up (1476); Adverse Event Without Identified Device or Use Problem (2993); Physical Resistance/Sticking (4012); Application Program Freezes, Becomes Nonfunctional (4031)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 11/11/2021

Event Type  malfunction  

Manufacturer Narrative

Concomitant medical products: other relevant device(s) are: product id: bi71000176, serial/lot #: (b)(4); product id: bi71000195, serial/lot #: (b)(4): a medtronic representative went to the site to test the equipment.Testing revealed that hardware parts were replaced.The imaging system then passed the system checkout and was found to be fully functional.The power conversion enclosure was returned to the manufacturer for analysis.Analysis found that the reported issue could be confirmed.The transistors were shorted.Analysis found that the reported event was related to an electrical issue.The power tray was returned to the manufacturer for analysis.Analysis found that the reported issue could be confirmed; the fuses were open which caused the power tray to fail.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 system being used outside of a procedure.It was reported that the image acquisition system (ias) would not boot up, while the mobile viewing station (mvs) worked normally.When opening the cover, the representative found that the fuses at the power tray were blown and that the power conversion was burned and cracked.The probable cause of the issue was that the power conversion enclosure was damaged.This issue was found when checking the system to prepare for a case.

• Brand Name: O-ARM O2 IMAGING SYSTEM
• 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: glen belmer ; 7000 central avenue ne rcw215; minneapolis, MN 55432 ; 6122713209
• MDR Report Key: 13307620
• MDR Text Key: 284708483
• Report Number: 3006544299-2022-00016
• Device Sequence Number: 1
• Product Code: OWB
• Combination Product (y/n): N
• Reporter Country Code: TH
• PMA/PMN Number: K200074
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Company Representative
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 01/20/2022

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: BI70002000
• Device Catalogue Number: BI70002000
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/28/2021
• Initial Date Manufacturer Received: 01/10/2022
• Initial Date FDA Received: 01/20/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/07/2019
• 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