MAUDE Adverse Event Report: SHIMADZU MEDICAL SYSTEMS RADSPEED GENERAL X-RAY SYSTEM; SYSTEM, X-RAY, STATIONARY

Model Number RADSPEED

Device Problem No Display/Image (1183)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 04/28/2019

Event Type  malfunction  

Event Description

Tech said she took a radiological image on the upright wall stand and received no image after producing x-ray.Corrective action did not recover a pt image.Problem occurred while using a general x-ray room and a digital image capture system.

• Brand Name: RADSPEED GENERAL X-RAY SYSTEM
• Type of Device: SYSTEM, X-RAY, STATIONARY
• Manufacturer (Section D): SHIMADZU MEDICAL SYSTEMS ; 20101 vermont ave; torrance CA 90502
• MDR Report Key: 8731363
• MDR Text Key: 149253016
• Report Number: MW5087594
• Device Sequence Number: 1
• Product Code: KPR
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 06/07/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/24/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: RADSPEED
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Was Device Evaluated by Manufacturer?: No Information
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 69 YR