MAUDE Adverse Event Report: GE MEDICAL SYSTEMS, LLC GE 1.5T SIGNA HDX MR SYSTEM; NUCLEAR MAGNETIC RESONANCE IMAGING

Device Problems Use of Device Problem (1670); Unintended Movement (3026)

Patient Problems Pain (1994); Skin Irritation (2076); Ulcer (2274); Pressure Sores (2326)

Event Date 06/17/2020

Event Type  Injury  

Manufacturer Narrative

Unique identifier: udi not required.There are no additional device identification numbers at this time, requested but not yet received.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 underwent bilateral shoulder exams.The patient was padded between the bore and arms, however due to involuntary movement, the pads may have shifted.The patient complained of elbow pain and was reported to present with redness on the skin of the left elbow.The patient was seen by plastic surgery who diagnosed the area on the elbow as pressure ulcer versus an rf burn.Treatment was provided by plastic surgery for the pressure ulcers.Information provided by the customer states the patient was in the scanner for two hours.

Manufacturer Narrative

H3: the investigation by ge healthcare (gehc) has been completed.The mr system was operating within specifications when checked by the gehc field engineer.The patient was padded between the bore and arms, however, due to involuntary movement, the pads may have shifted.The patient's pre-existing conditions contributed to the severity.Based on the information received, this incident occurred due to moving and positioning of the patient.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: GE 1.5T SIGNA HDX MR SYSTEM
• Type of Device: NUCLEAR MAGNETIC RESONANCE IMAGING
• Manufacturer (Section D): GE MEDICAL SYSTEMS, LLC; 3200 n grandview blvd.; waukesha, WI 53188
• MDR Report Key: 10368443
• MDR Text Key: 201833264
• Report Number: 2183553-2020-00013
• Device Sequence Number: 1
• Product Code: LNH
• Combination Product (y/n): N
• PMA/PMN Number: K052293
• 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: 09/23/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/05/2020
• 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: 08/28/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 62 YR
• Patient Weight: 100