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

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

Patient Problems Laceration(s) (1946); Electric Shock (2554)

Event Date 02/13/2022

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.Device evaluation anticipated, but not yet begun.

Event Description

It was reported that during patient preparation, a ferrous office chair was used to transport the patient to the mr table.When the patient got up, the chair became attracted to the magnet and struck the lip of the hospital technician.The lip laceration required sutures.Following the event, the chair was safely removed from the magnet.

Manufacturer Narrative

H3: the investigation by ge healthcare (gehc) has been completed.The office chair, introduced into the magnet room to transport the patient to the mr table, was attracted by the magnet during patient preparation.When the patient left the chair, the chair was attracted by the magnet with no injury to the patient but hitting a technician from the hospital in the face.The customer site has an mr safety manual, the individual involved has been trained in magnet safety and the security zone warning sign was posted to the entry of the magnet room.Based on the information reviewed, the root cause appears to be inattentive personnel which is a use error.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 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 30030 8; CH 300308
• Manufacturer (Section G): GE HEALTHCARE (TIANJIN) COMPANY LIMITED; no.266 jingsan road; tianjin airport economic area; tianjin 30030 8; CH 300308
• Manufacturer Contact: andy koch ; 3200 n. grandview blvd.; waukesha, WI 53188
• MDR Report Key: 13695505
• MDR Text Key: 286838860
• Report Number: 3010949642-2022-00004
• Device Sequence Number: 1
• Product Code: LNH
• Combination Product (y/n): N
• Reporter Country Code: SP
• PMA/PMN Number: K161567
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,User Facility,Company Representative
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 10/03/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/08/2022
• 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: 10/03/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/01/2020
• 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
• Patient Outcome(s): Other
• Patient Age: 45 YR
• Patient Sex: Female
• Patient Weight: 70 KG