MAUDE Adverse Event Report: GE HANGWEI MEDICAL SYSTEMS CO., LTD. PROTEUS XR/A RADIOGRAPHIC SYSTEM; SYSTEM, X-RAY, STATIONARY

Model Number 2259973-3

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

Patient Problem Radiation Burn (1755)

Event Date 08/12/2019

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 weight was not provided by the initial reporter.Device evaluation anticipated, but not yet begun.

Event Description

On 27-sep-2019, the radiology director at (b)(6) hospital in the united states reported to ge healthcare that upon completion of two chest x-rays performed on a ge proteus radiographic system on (b)(6) 2019, there was an alleged radiation burn on a patient.The patient received both posterior-anterior (pa) and lateral (lat) chest x-rays.After approximately three days, the patient returned to (b)(6) hospital and was seen by a nurse practitioner who diagnosed the injury as a radiation burn located on the patient's back.At this time, it is not known if the ge system caused or contributed to the injury.

Manufacturer Narrative

Ge healthcare investigation has been completed and it was determined the ge proteus radiographic system did not cause or contribute to this injury.A ge healthcare field engineer (fe) investigated the system and could not identify any system malfunction.The fe also tested the techniques as well as the half value layer and all testing passed.A chest x-ray exposes the patient to a very small amount of x-ray radiation.Two chest shots (pa/lat) would not be reasonably expected to have produced a sensation of burning nor would it cause radiodermatitis.Based solely on the description of events, the rectangular shape of the injury is also inconsistent with the radiation field size that was verified as being used by the customer.Normally the x-ray radiation energy is spread out equally based on the field size.In this event, the alleged burn area was a regularly defined rectangular 11x6 inch area which did not match the radiation field size of 14x17 inches.The threshold for radiation dermatitis is approximately 5gy.Radiation doses of this magnitude and above are also associated with temporary or permanent loss of hair in the affected region, transient erythema (reddening of the skin), and at very high doses, dermal atrophy (destruction of the underlying tissue compartments).Two brief chest x-rays would not reach these levels.There was also no confirmed diagnoses by a dermatologist.Other similar such manifestations may also be associated with a contact irritant/allergic reaction, and less likely related to an energy-based delivery.

• Brand Name: PROTEUS XR/A RADIOGRAPHIC SYSTEM
• Type of Device: SYSTEM, X-RAY, STATIONARY
• 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: 9205479
• MDR Text Key: 162866855
• Report Number: 9613445-2019-00008
• Device Sequence Number: 1
• Product Code: KPR
• Combination Product (y/n): N
• PMA/PMN Number: K993090
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,user faci
• Type of Report: Initial,Followup
• Report Date: 11/15/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 2259973-3
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 09/17/2019
• Initial Date FDA Received: 10/17/2019
• Supplement Dates Manufacturer Received: 11/15/2019
• Supplement Dates FDA Received: 11/15/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 85 YR