MAUDE Adverse Event Report: SIEMENS MEDICAL SOLUTIONS SOMATOM SENSATION 64; SYSTEM, X-RAY, TOMOGRAPHY, COMPUTED

Model Number 8377520

Device Problems Device Displays Incorrect Message (2591); Appropriate Term/Code Not Available (3191)

Patient Problem Insufficient Information (4580)

Event Date 06/23/2021

Event Type  malfunction  

Event Description

During the patient's ct scan, the ct machine briefly paused and caused a delay in the timing of the scan.Siemens was contacted and a service request was placed.Corrective action/service performed : replaced vega p/s.System still aborts checkup and cal with dom_3003 and xdc-3003 errors.Will continue work on 2nd notification for same fl.Task remains open for possible rsc evaluation.

• Brand Name: SOMATOM SENSATION 64
• Type of Device: SYSTEM, X-RAY, TOMOGRAPHY, COMPUTED
• Manufacturer (Section D): SIEMENS MEDICAL SOLUTIONS; 40 liberty boulevard; mailcode: 64-1a; malvern PA 19355
• MDR Report Key: 12438230
• MDR Text Key: 270287983
• Report Number: 12438230
• 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: 08/31/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/08/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Model Number: 8377520
• 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: 08/31/2021
• Event Location: Hospital
• Date Report to Manufacturer: 09/08/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Age: 25915 DA