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

Lot Number 540981SMCT3

Device Problem Intermittent Energy Output (4025)

Patient Problem Unintended Radiation Exposure (4565)

Event Date 02/22/2022

Event Type  malfunction  

Event Description

Scan was stopped mid-scan, not by user, requiring patient to be re-exposed to include all required anatomy for ordered exam.

• Brand Name: SOMATOM SENSATION 64
• Type of Device: SYSTEM, X-RAY, TOMOGRAPHY, COMPUTED
• Manufacturer (Section D): SIEMENS MEDICAL SOLUTIONS USA, INC.; 810 innovation dr; knoxville IL 37932
• MDR Report Key: 15347599
• MDR Text Key: 299470857
• Report Number: 15347599
• 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: Other Health Care Professional
• Type of Report: Initial
• Report Date: 02/22/2022

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 Lot Number: 540981SMCT3
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 02/22/2022
• Event Location: Hospital
• Date Report to Manufacturer: 09/02/2022
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 09/02/2022
• Type of Device Usage: Unknown
• Patient Sequence Number: 1