MAUDE Adverse Event Report: SIEMENS HEALTHCARE GMBH SYSTEM SOMATOM DEFINITION AS; SYSTEM, X-RAY, TOMOGRAPHY, COMPUTED

Model Number 08098027

Device Problems Power Problem (3010); Unexpected Shutdown (4019)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 04/13/2021

Event Type  malfunction  

Event Description

Patient was being scanned with iv contrast when the computerized tomography (ct) received power faults on the screen and shut down while scanning.Ct gated thorax was scanned with 2/3 of the heart only visualized due to scanner shutting down.Imaging was processed up to the point that the scanner shutdown.Patient study may be sufficient, but study is considered incomplete due to the portion of heart missing from study.Patient was told that radiologist will read study and notify ordering md of results.Patient sent home with no complaints.Scanner affected: siemens somatom definition as in the mp 200.Siemens service was called and placed complaint.

• Brand Name: SYSTEM SOMATOM DEFINITION AS
• Type of Device: SYSTEM, X-RAY, TOMOGRAPHY, COMPUTED
• Manufacturer (Section D): SIEMENS HEALTHCARE GMBH; 40 liberty boulevard mailcode: 65-1a; malvern PA 19355
• MDR Report Key: 11699887
• MDR Text Key: 246482071
• Report Number: 11699887
• 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: 04/14/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/21/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 08098027
• Device Catalogue Number: 400110647757
• 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: 04/14/2021
• Event Location: Outpatient Treatment Facility
• Date Report to Manufacturer: 04/21/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Age: 14235 DA
• Patient Weight: 83