MAUDE Adverse Event Report: GE HEALTHCARE (TIANJIN) COMPANY LIMITED 1.5T SIGNA VOYAGER; NUCLEAR MAGNETIC RESONANCE IMAGING

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Suture Abrasion (2497)

Event Date 03/17/2018

Event Type  Injury  

Manufacturer Narrative

(b)(4).There are no additional device identification numbers.Ge healthcare performed an investigation.The incident occurred due to inattentive personnel.The technologist was magnet safety trained, magnet safety signs are posted and the site has a copy of the mr safety manual.The ge healthcare field engineer was able to safely remove the iv pole from the magnet.No further actions are planned at this time.

Event Description

It was reported that an mr technologist brought an iv pole into the scan room.The tech thought it was an mr compatible iv pole however, it was ferrous and when brought into the room, it became attracted to the magnet.The tech tried to remove the iv pole which resulted in an injury to the right hand.The tech was seen in the emergency room where the tech received 16 stitches to two fingers.

Manufacturer Narrative

Corrected data: a2.

• Brand Name: 1.5T SIGNA VOYAGER
• Type of Device: NUCLEAR MAGNETIC RESONANCE IMAGING
• Manufacturer (Section D): GE HEALTHCARE (TIANJIN) COMPANY LIMITED; no.266 jingsan road; tianjin airport economic area; tianjin ; CH
• MDR Report Key: 7455152
• MDR Text Key: 106331450
• Report Number: 3010949642-2018-00002
• Device Sequence Number: 1
• Product Code: LNH
• Combination Product (y/n): N
• PMA/PMN Number: K161567
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 01/07/2019

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: Health Professional
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 03/29/2018
• Initial Date FDA Received: 04/24/2018
• Supplement Dates Manufacturer Received: 12/21/2018
• Supplement Dates FDA Received: 01/07/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 63 YR
• Patient Weight: 90