MAUDE Adverse Event Report: KONICA MINOLTA, INC. RADIOLOGY XR7 FILM READER/ FILM RADIOGRAPHIC

Model Number CS-3

Device Problems Loss of Power (1475); Loss of Data (2903); Device Operates Differently Than Expected (2913)

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

Event Date 05/14/2018

Event Type  malfunction  

Event Description

Konica reader shut down due to hard drive failure.Radiology images lost.Patient needed images retaken.

• Brand Name: RADIOLOGY XR7 FILM READER/ FILM RADIOGRAPHIC
• Type of Device: RADIOLOGY XR7 FILM READER/ FILM RADIOGRAPHIC
• Manufacturer (Section D): KONICA MINOLTA, INC.
• MDR Report Key: 7548987
• MDR Text Key: 109544860
• Report Number: MW5077469
• Device Sequence Number: 1
• Product Code: IWZ
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 05/23/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/25/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: CS-3
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• 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: 50 YR