MAUDE Adverse Event Report: GE MEDICAL SYSTEMS, LLC CT 4 HYBRID; SYSTEM, X-RAY, TOMOGRAPHY, COMPUTED

Device Problem Therapeutic or Diagnostic Output Failure (3023)

Patient Problem Insufficient Information (4580)

Event Date 07/01/2021

Event Type  malfunction  

Event Description

Machine failed post scout images x2.New cable installed for ecg signal to transfer to scanner.Fda safety report id# (b)(4).

• Brand Name: CT 4 HYBRID
• Type of Device: SYSTEM, X-RAY, TOMOGRAPHY, COMPUTED
• Manufacturer (Section D): GE MEDICAL SYSTEMS, LLC
• MDR Report Key: 12134810
• MDR Text Key: 260604392
• Report Number: MW5102335
• Device Sequence Number: 1
• Product Code: JAK
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Type of Report: Initial
• Report Date: 07/02/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/06/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: 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: 79 YR