MAUDE Adverse Event Report: MEDTRONIC NAVIGATION, INC (LITTLETON) O-ARM 1000 IMAGING SYSTEM 3RD EDITION; IMAGE-INTENSIFIED FLUOROSCOPIC X-RAY SYSTEM, M

Model Number BI70000027230R

Device Problems Failure to Run on Battery (1466); Power Problem (3010); Application Program Freezes, Becomes Nonfunctional (4031)

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

Event Date 01/26/2022

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.

Event Description

Medtronic received information regarding an imaging system.It was reported outside of a procedure that the batteries and chargers were malfunctioning.A few battery pairs were below the recommended level.The chargers provided too much power.The system was not able to start exposition.  no patient was present at the time of the event.Additional information was received.It was reported that the imaging system could boot up, however x-ray could not be performed.It was noted that voltage on the standalone board would drop when attempting an image acquisition.Troubleshooting found that non-medtronic batteries were installed in the imaging system and the batteries caused the reported issue.

• Brand Name: O-ARM 1000 IMAGING SYSTEM 3RD EDITION
• Type of Device: IMAGE-INTENSIFIED FLUOROSCOPIC X-RAY SYSTEM, M
• 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: glen belmer ; 7000 central avenue ne rcw215; minneapolis, MN 55432 ; 6122713209
• MDR Report Key: 13549727
• MDR Text Key: 287329572
• Report Number: 3004785967-2022-00115
• Device Sequence Number: 1
• Product Code: OXO
• Combination Product (y/n): N
• Reporter Country Code: CY
• 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: 02/17/2022

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 Model Number: BI70000027230R
• Device Catalogue Number: BI70000027230R
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 01/26/2022
• Initial Date FDA Received: 02/17/2022
• Was Device Evaluated by Manufacturer?: No
• 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