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

Model Number RADSPEED PRO

Device Problems Computer Software Problem (1112); Loss of Data (2903)

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

Event Date 08/21/2019

Event Type  malfunction  

Event Description

This occurred on a general rad room.Digital pt images were lost due to software corruption.New software was loaded, wasn't realized till after the site tried to take pt images that the networking wasn't working.Windows software was updated which corrupted the medical x-ray images causing them to be unrecoverable.

• Brand Name: RADSPEED PRO
• Type of Device: SYSTEM, X-RAY, STATIONARY
• Manufacturer (Section D): SHIMADZU MEDICAL SYSTEMS
• MDR Report Key: 9213731
• MDR Text Key: 163114473
• Report Number: MW5090484
• 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: 10/02/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/18/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/01/2020
• Device Model Number: RADSPEED PRO
• 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: 77 YR
• Patient Weight: 102