MAUDE Adverse Event Report: RAYENCE & MYVET INC. RAYENCE XRAY DETECTOR; SOLID STATE X-RAY IMAGER (FLAT PANEL/DIGITAL IMAGER)

Model Number 1717SCC-140

Device Problem Defective Component (2292)

Patient Problem Insufficient Information (4580)

Event Date 11/15/2021

Event Type  malfunction  

Event Description

An equipment manufacturer, rayance, has installed a defective component known as a "detector." this component is the root cause of xray images including artifacts in xray images.The artifacts are a serious detriment to accurate interpretation by a radiologist and significantly affects risk of incorrect diagnosis' to patients.Company well aware of the risk to patients and is completely unresponsive to inquires requesting equitable resolution.All images created on this piece of equipment are out of compliance.Fda safety report id # (b)(4).

• Brand Name: RAYENCE XRAY DETECTOR
• Type of Device: SOLID STATE X-RAY IMAGER (FLAT PANEL/DIGITAL IMAGER)
• Manufacturer (Section D): RAYENCE & MYVET INC.
• MDR Report Key: 13561391
• MDR Text Key: 285985033
• Report Number: MW5107570
• Device Sequence Number: 1
• Product Code: MQB
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 02/15/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/17/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Model Number: 1717SCC-140
• Was Device Available for Evaluation?: Yes
• Patient Sequence Number: 1