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

Device Problem Therapeutic or Diagnostic Output Failure (3023)

Patient Problem No Code Available (3191)

Event Date 05/09/2020

Event Type  malfunction  

Event Description

During scan right after injection of contrast the scanner stopped and nurse got a hardware stop and had to go back to select a new protocol and re-inject patient to scan the axial.It was a scanner hardware stop, restarted scanner afterwards and was able to perform scan.

• Type of Device: SYSTEM, X-RAY, TOMOGRAPHY, COMPUTED
• Manufacturer (Section D): GE MEDICAL SYSTEMS, INC.; 3000 n grandview blvd; waukesha WI 53188
• MDR Report Key: 10167170
• MDR Text Key: 195550995
• Report Number: 10167170
• Device Sequence Number: 1
• Product Code: JAK
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 05/12/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/18/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 05/12/2020
• Event Location: Hospital
• Date Report to Manufacturer: 06/18/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 17885 DA