MAUDE Adverse Event Report: GE MEDICAL SYSTEMS, LLC MAGNETIC RESONANCE DIAGNOSTIC SYSTEM; NUCLEAR MAGNETIC RESONANCE IMAGING

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

Patient Problems Burn(s) (1757); Full thickness (Third Degree) Burn (2696)

Event Date 03/21/2019

Event Type  Injury  

Manufacturer Narrative

Unique identifier: udi_not_required.Suspect medical device: there are no additional device identification numbers.Device evaluated by mfr: 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 undergoing an mri of the knee sustained a 3rd degree burn to the left hip that was 6cm in size.The patient was reported to have been in contact with the bore of the magnet and had not been padded to prevent contact to the sides of the magnet bore or to prevent skin to skin contact.

Manufacturer Narrative

The investigation by ge healthcare (gehc) has been completed.The mr system was operating within specifications and all safety mitigating devices, including the redundant rf power monitors, were functional when checked by the ge healthcare 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: MAGNETIC RESONANCE DIAGNOSTIC SYSTEM
• Type of Device: NUCLEAR MAGNETIC RESONANCE IMAGING
• Manufacturer (Section D): GE MEDICAL SYSTEMS, LLC; 3200 n grandview blvd.; waukesha, WI 53188
• Manufacturer Contact: jacqui budde ; 3200 n. grandview blvd.; waukesha, WI
• MDR Report Key: 8561224
• MDR Text Key: 143431618
• Report Number: 2183553-2019-00007
• Device Sequence Number: 1
• Product Code: LNH
• Combination Product (y/n): N
• Reporter Country Code: GR
• PMA/PMN Number: K962061
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 06/06/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/29/2019
• Is this an Adverse Event Report?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 04/04/2019
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/01/1970
• 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: 56 YR
• Patient Weight: 120