MAUDE Adverse Event Report: GE MEDICAL SYSTEMS INFORMATION TECH.; SYSTEM, X-RAY, TOMOGRAPHY

Device Problem Device Inoperable (1663)

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

Event Date 08/18/2014

Event Type  malfunction  

Event Description

Patient was brought into ct.The patient stated that his weight was 360 lbs.The table limit is 450 lbs.Exams were started.Scout was successful.The contrast was started with a good contrast bolus.The scan was started and the table stopped.The scan was tried again, and the scanner stopped working.The table worked on following ct-scans.

• Type of Device: SYSTEM, X-RAY, TOMOGRAPHY
• Manufacturer (Section D): GE MEDICAL SYSTEMS INFORMATION TECH.; 9900 innovation dr,rp 2138; wauwatosa WI 53226
• MDR Report Key: 4137585
• MDR Text Key: 4946342
• Report Number: 4137585
• Device Sequence Number: 1
• Product Code: JAK
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Invalid Data
• Type of Report: Initial
• Report Date: 09/26/2014

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: Invalid Data
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 09/26/2014
• Event Location: Hospital
• Date Report to Manufacturer: 10/03/2014
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 09/26/2014
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: THE TIME OF THE EVENT.; NO OTHER DEVICES WERE BEING USED ON THE PATIENT AT
• Patient Age: 68 YR
• Patient Weight: 163