MAUDE Adverse Event Report: TOSHIBA TOSHIBA CAT SCAN MACHINE

Device Problems Sticking (1597); Device Inoperable (1663)

Patient Problems Pain (1994); No Consequences Or Impact To Patient (2199)

Event Date 09/25/2015

Event Type  malfunction  

Event Description

A cat scan was performed on an ed pt presenting with abdominal pain.The ct images got stuck in the system, the machine was shutdown by request of biomed, and could not be retrieved once it was restarted.This delayed the images being read.But, there was no harm reported with delay to the pt.

• Brand Name: TOSHIBA CAT SCAN MACHINE
• Type of Device: TOSHIBA CAT SCAN MACHINE
• Manufacturer (Section D): TOSHIBA
• MDR Report Key: 5123950
• MDR Text Key: 27461233
• Report Number: MW5056757
• Device Sequence Number: 1
• Product Code: JAK
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Nurse
• Report Date: 09/28/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 09/28/2015
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 61 YR
• Patient Weight: 54