MAUDE Adverse Event Report: MEDTRONIC NAVIGATION, INC. O-ARM; IMAGE-INTENSIFIED FLUOROSCOPIC X-RAY SYSTEM, MOBILE

Model Number BI-700-00027-120

Device Problem Therapeutic or Diagnostic Output Failure (3023)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 10/25/2019

Event Type  malfunction  

Event Description

Biomed received a call from operating room lead x-ray tech, as o-arm became unresponsive during a surgery.This caused a 15 minute delay (while patient was maintained and monitored under anesthesia) in surgery.Staff tried a shutdown and manual reboot of just the o-arm but with no luck.He then accomplished a complete system shutdown and reboot, and this was successful.Biomed called medtronic after this and placed a service call for the unresponsiveness of o-arm during a surgery.The intent is to have medtronic remotely pull logs from the o-arm for analysis.Medtronic has been working with hospital bio engineers to get the logs as requested by medtronic fse and they've just been sent from hospital to medtronic.Manufacturer response for o-arm, (brand not provided) (per site reporter).We received an e-mail from the medtronic fse (field service engineer) asking if our hospital could obtain the logs and e-mail to them.That was done the afternoon of this report after the o-arm is in done with use today.The case today went along with no issues.

• Brand Name: O-ARM
• Type of Device: IMAGE-INTENSIFIED FLUOROSCOPIC X-RAY SYSTEM, MOBILE
• Manufacturer (Section D): MEDTRONIC NAVIGATION, INC.; 300 foster street; littleton MA 01460
• MDR Report Key: 9659290
• MDR Text Key: 177374032
• Report Number: 9659290
• Device Sequence Number: 1
• Product Code: OXO
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 10/28/2019

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: Other
• Device Model Number: BI-700-00027-120
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 10/28/2019
• Device Age: 5 YR
• Event Location: Hospital
• Date Report to Manufacturer: 02/03/2020
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 02/03/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 19345 DA
• Patient Weight: 63