MAUDE Adverse Event Report: NON-MR COMPATIBLE OXYGEN TANK; GENERATOR, OXYGEN, PORTABLE

Device Problem Improper or Incorrect Procedure or Method (2017)

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

Event Date 05/17/2019

Event Type  Injury  

Event Description

Pt came down to mr dept on non-mr compatible oxygen tank.Tank was placed under pt's knees under a blanker.Pt was moved from hosp bed to detachable mr exam table.Staff did not follow current safety process in place and never wanded the pt prior to entering zone 4 with a metal detector.Pt was brought into the room and setup for exam.When staff went to raise their legs to put a pillow underneath, they noticed an oxygen tank.Staff quickly removed the tank from zone 4 and no harm was done to the pt or equipment.The issue was reported to radiology leadership and an internal investigation of our policies and practices took place which showed that if the safety measures we have in place were utilized correctly there would not have been an issue.

• Brand Name: NON-MR COMPATIBLE OXYGEN TANK
• Type of Device: GENERATOR, OXYGEN, PORTABLE
• MDR Report Key: 8687884
• MDR Text Key: 147849251
• Report Number: MW5087266
• Device Sequence Number: 1
• Product Code: CAW
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial
• Report Date: 05/28/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 06/10/2019
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 68 YR
• Patient Weight: 93