MAUDE Adverse Event Report: MEDTRONIC NAVIGATION, INC (LITTLETON) O-ARM O2 IMAGING SYSTEM; INTERVENTIONAL FLUOROSCOPIC X-RAY SYSTEM

Model Number BI70002000

Device Problem Failure to Run on Battery (1466)

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

Event Date 12/07/2020

Event Type  malfunction  

Manufacturer Narrative

Concomitant medical products: product id: bi71000162, serial/lot #: unknown.A medtronic representative went to the site to test the system.Testing revealed that tray 8 was bad, or has a bad cell.Replaced tray 8.Voltage remained stable after.The system then passed the system checkout and was found to be fully functional.If information is provided in the future, a supplemental report will be issued.

Event Description

Medtronic received information from a manufacturer representative (rep) regarding a device being used outside of a procedure.It was reported that the o2 battery is draining faster than normal.There was no patient harm or additional complications reported or anticipated as a result of the event.

• Brand Name: O-ARM O2 IMAGING SYSTEM
• Type of Device: INTERVENTIONAL FLUOROSCOPIC X-RAY SYSTEM
• Manufacturer (Section D): MEDTRONIC NAVIGATION, INC (LITTLETON); 300 foster st; littleton MA 01460
• Manufacturer (Section G): MEDTRONIC NAVIGATION, INC (LITTLETON); 300 foster st; littleton MA 01460
• Manufacturer Contact: tricha miles ; 7000 central avenue ne rcw215; minneapolis, MN 55432 ; 7635140379
• MDR Report Key: 11023724
• MDR Text Key: 222074276
• Report Number: 3004785967-2020-01523
• Device Sequence Number: 1
• Product Code: OWB
• UDI-Device Identifier: 00643169639683
• UDI-Public: 00643169639683
• 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
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 12/16/2020

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?: No
• Initial Date Manufacturer Received: 12/07/2020
• Initial Date FDA Received: 12/16/2020
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/23/2018
• 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