MAUDE Adverse Event Report: GE MEDICAL SYSTEMS, LLC SIGNA ARCHITECT; NUCLEAR MAGNETIC RESONANCE IMAGING

Device Problem Use of Device Problem (1670)

Patient Problem Burn(s) (1757)

Event Date 04/11/2019

Event Type  Injury  

Manufacturer Narrative

Unique identifier: (b)(4).Suspect medical device: there are no additional device identification numbers.Device evaluated by mfr: the investigation by ge healthcare (gehc) has been completed.A gehc field engineer completed system testing and verified that the mri scanner was operating normally and within performance specifications.The root cause was determined to be operator error related to the use of a 3rd party medtronic axiem non-invasive patient tracker (nipt) during the patient mri scan.Per discussion with the user, the medtronic mr conditions for use were not strictly followed during this procedure, resulting in an rf burn to the patient.Per our gehc operator manual, the user must ensure the safe use of mr conditional devices during patient scans.Users should consult the device manufacturer's instructions and safety guidelines.No further actions are planned by gehc.Medtronic has been notified of the patient event involving their product.

Event Description

It was reported that a patient sustained a burn injury to the scalp during an intra-operative mri procedure utilizing a medtronic axiem non-invasive patient tracker (nipt).The burn injury occurred at a point of contact directly between the nipt tracker and the patient's scalp.The patient was assessed at the site and diagnosed with a 2cm by 2cm superficial burn on the scalp that was treated with silvadene.The customer reported this to be a superficial burn; however, ge healthcare has conservatively assessed this as a serious injury due to several factors including the appearance and anatomical location of the patient's burn.

• Brand Name: SIGNA ARCHITECT
• 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: 8595646
• MDR Text Key: 144601987
• Report Number: 2183553-2019-00008
• Device Sequence Number: 1
• Product Code: LNH
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K163331
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 05/09/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/09/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 04/15/2019
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/23/2017
• 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: 32 YR
• Patient Weight: 80