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

Device Problems Electromagnetic Interference (1194); Use of Device Problem (1670)

Patient Problem Laceration(s) (1946)

Event Date 04/12/2021

Event Type  Injury  

Manufacturer Narrative

Unique identifier: (b)(4).There are no additional device identification numbers.Ge healthcare's investigation is ongoing.A follow up report will be submitted once the investigation has been completed.

Event Description

It was reported that during a system upgrade, the ge field engineer was changing the cable pit lid and brought one ferrous lid into the magnet room.While attempting to remove the lid from the scan room, it became attracted to the magnet, lacerating his finger in the process.The laceration required two stitches.Additionally, his fingernail was pierced to drain the blood.

Manufacturer Narrative

H3: the investigation by ge healthcare (gehc) has been completed.Based on the information provided, the incident occurred during a system upgrade.The field engineer (fe) contacted a contractor to create a non-magnetic pit lid, but instead of waiting for the non-magnetic lid, the fe made the decision to continue with a magnetic lid.After the fe finished system calibration and just before turning the system over to the customer for application training, the fe realized he re-installed the ferrous lid so he rushed to take it out of the scan room when it was attracted to magnet.The fe released the lid with his left hand but maintained his hold with his right hand.The fe injured his hand when it got caught between the ferrous lid and the magnet.The magnet was ramped down to facilitate the removal of the lid.This ferrous lid was labeled and taken out of scan room.The root cause was determined to be a user issue as the fe did not follow standard safety procedures.The mr service safety manual and installation manual clearly define the risks associated with entering the scan room with ferrous materials when the magnet is at field.No further actions are planned by gehc.

• Brand Name: SIGNA EXPLORER
• Type of Device: NUCLEAR MAGNETIC RESONANCE IMAGING
• Manufacturer (Section D): GE HEALTHCARE (TIANJIN) COMPANY LIMITED; no.266 jingsan road; tianjin airport economic area; tianjin 30030 8; CH 300308
• MDR Report Key: 11804970
• MDR Text Key: 251123068
• Report Number: 3010949642-2021-00004
• Device Sequence Number: 1
• Product Code: LNH
• Combination Product (y/n): N
• PMA/PMN Number: K143251
• 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: 08/17/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/11/2021
• 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
• Date Manufacturer Received: 07/20/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 30 YR
• Patient Weight: 75