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

Model Number BI70002000

Device Problem Application Program Freezes, Becomes Nonfunctional (4031)

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

Event Date 12/10/2020

Event Type  malfunction  

Manufacturer Narrative

No patient information provided as no patient was involved in this concern.No parts have been received by the manufacturer for evaluation.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 the site was trying to get a system ready for a case when it got stuck in initializing please wait.They rebooted the system and they were able to continue on.

• 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: tricha miles ; 7000 central avenue ne rcw215; minneapolis, MN 55432 ; 7635140379
• MDR Report Key: 11095598
• MDR Text Key: 225554734
• Report Number: 3006544299-2020-00510
• 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: K200074
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 12/30/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/30/2020
• 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
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/10/2020
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 02/08/2019
• 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