MAUDE Adverse Event Report: GE MEDICAL SYSTEMS, LLC AMX-4 PLUS MOBILE X-RAY SYSTEM; SYSTEM, X-RAY, MOBILE

Model Number 2169360

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Radiation Burn (1755)

Event Date 06/18/2018

Event Type  Injury  

Manufacturer Narrative

Ge healthcare has initiated an investigation which is ongoing.A follow-up report will be submitted upon completion of the investigation.Although requested, patient age and weight were not provided by the initial reporter.Device evaluation anticipated, but not yet begun.

Event Description

On 22-jul-2019, ge healthcare became aware of an incident that occurred on (b)(6) 2018 at (b)(6) medical center in the (b)(6) where a patient alleged they received a radiation burn after receiving a chest x-ray using an amx 4 plus mobile radiographic device.

Manufacturer Narrative

Ge healthcareâs investigation has been completed and it was determined the amx 4 plus mobile radiographic system did not cause or contribute to the patientâs radiation burn.A ge field engineer (fe) investigated the system and determined there was no malfunction and the system was operating normally.The customer was interviewed, and it was discovered the patient had recently undergone an angioplasty procedure at another hospital and then was admitted at vrp medical center (vrpmc) for a surgical pacemaker insertion procedure in addition to an x-ray procedure using a ge amx 4 plus mobile system to check the pacemaker placement.The amx 4 plus procedure performed was a chest ap.Two exposures were taken using the parameters 85kv with 8mas because the first image contained image quality due to patient movement.Although requested, the customer would not provide any additional information regarding the three procedures referenced above.The patient then returned to vrpmc at an unknown date and complained of a burn on his back.The patient claimed the cause for burn was due to the last procedure he received which was the chest ap on the amx system.The patient assumed the amx was at fault because it was the last procedure completed in addition to the fact the image receptor was in contact with his back.

• Brand Name: AMX-4 PLUS MOBILE X-RAY SYSTEM
• Type of Device: SYSTEM, X-RAY, MOBILE
• Manufacturer (Section D): GE MEDICAL SYSTEMS, LLC; 3000 north grandview boulevard; waukesha, WI 53188
• MDR Report Key: 8917059
• MDR Text Key: 155088181
• Report Number: 2126677-2019-00011
• Device Sequence Number: 1
• Product Code: IZL
• Combination Product (y/n): N
• PMA/PMN Number: K021016
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,user facility
• Type of Report: Initial,Followup
• Report Date: 10/03/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/21/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 2169360
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 09/26/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other