MAUDE Adverse Event Report: GE HANGWEI MEDICAL SYSTEMS CO., LTD. BRIVO MR355; NUCLEAR MAGNETIC RESONANCE IMAGING

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

Patient Problems Pain (1994); Blood Loss (2597); Foreign Body In Patient (2687)

Event Date 07/13/2020

Event Type  Injury  

Manufacturer Narrative

Unique identifier: udi_not_required.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 a patient, who was injured in a farming incident when an object struck his leg, underwent an mri.The patient was unaware that the object had actually entered his leg.When placed into the scanner, the patient complained of pain.After multiple attempts at a localizer where artifacts were seen, the exam was ended.When the technologist entered the room, blood was seen on the equipment which was coming from the area in the patient's leg where he had been struck.First aid was provided by the nurse in the scan room.The patient was then taken to icu where surgery was scheduled to remove the foreign body lodged in the patient's leg.

Manufacturer Narrative

H3: the investigation by ge healthcare (gehc) has been completed.Based on the information provided, the incident occurred due to inattentive behavior by the technologist aid by introducing the patient with a ferrous object within a wound into the scan room.The labeling states the magnetic field of the mr system can cause a ferrous implant (e.G., surgical clip, cochlear implant, intracranial aneurysm clip, etc.) or prosthesis to move or be displaced, resulting in serious injury.Patients and mr workers should be screened for implants and those individuals with implants should, in general, not enter the scan room.The mr safety guide or the operator manual with integrated safety section, clearly defines the risks associated with owning and operating an mr scanner.Personnel trained in mr safety are to perform screening of individuals who will enter the magnet room.No further actions are planned by gehc.

• Brand Name: BRIVO MR355
• Type of Device: NUCLEAR MAGNETIC RESONANCE IMAGING
• Manufacturer (Section D): GE HANGWEI MEDICAL SYSTEMS CO., LTD.; west area of building no.3,; no.1 yongchang north road; beijing 10017 6; CH 100176
• MDR Report Key: 10398950
• MDR Text Key: 202686278
• Report Number: 9613445-2020-00004
• Device Sequence Number: 1
• Product Code: LNH
• Combination Product (y/n): N
• PMA/PMN Number: K123417
• 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: 10/09/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/12/2020
• 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: 09/18/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 62 YR
• Patient Weight: 72