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

Device Problems Use of Device Problem (1670); Improper or Incorrect Procedure or Method (2017)

Patient Problems Radiation Burn (1755); Burn(s) (1757); Erythema (1840); Blister (4537)

Event Date 03/29/2021

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 a patient, who was having a left shoulder exam and passed mr screening, sustained a 4-5cm deep red burn with blister on her arm.The blister was opened by a doctor and wound treatment was provided to aid the healing process.The patient's arms were on her chest and ge recommended pads were not provided to prevent bore or skin to skin contact or looping.

Manufacturer Narrative

H3: the investigation by ge healthcare (gehc) has been completed.The mr system was operating within specifications and all safety mitigating devices were functional when checked by the gehc field engineer.The root cause of the injury was determined to be inadequate patient padding for the mri procedure.The operator documentation describes the appropriate safety measures for padding patients for mr exams.The mr operator has the final responsibility for the use and placement of non-conductive mr compatible padding and preparation of the patient, prior to starting the mr exam procedure.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
• MDR Report Key: 11840603
• MDR Text Key: 251122389
• Report Number: 3010949642-2021-00006
• 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: 06/10/2021

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: 04/20/2021
• Initial Date FDA Received: 05/18/2021
• Supplement Dates Manufacturer Received: 06/06/2021
• Supplement Dates FDA Received: 06/10/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 36 YR
• Patient Weight: 70