MAUDE Adverse Event Report: FUJI FUJI CR CASSETTE READER; CP CASSETTE READER

Device Problem Loss of Data (2903)

Patient Problem Radiation Overdose (1510)

Event Date 03/23/2014

Event Type  malfunction  

Event Description

Patient went to ip radiology for a chest x-ray which needed to be completed in the sitting position.A z view seated chest x-ray was completed.The cr cassette was run through the cassette reader and an error message was given.The machine rescanned the cassette.An error message was given again and the image was deleted.The patient needed to undergo the x-ray again.Service call to adt was made for repair which occurred and the machine was put back into service when remediation completed.No patient harm.

• Brand Name: FUJI CR CASSETTE READER
• Type of Device: CP CASSETTE READER
• Manufacturer (Section D): FUJI
• MDR Report Key: 3874129
• MDR Text Key: 4592494
• Report Number: MW5036589
• Device Sequence Number: 1
• Product Code: MQB
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 06/06/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/06/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Other Device ID Number: ASSET 453898
• Is the Reporter a Health Professional?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 59 YR