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

Model Number SOMATOM SENSATION 64/CARDIAC 64

Device Problem Defective Component (2292)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 01/10/2019

Event Type  malfunction  

Event Description

Had a patient on the table for a ct scan of her chest.While performing the topogram the table made one click to move and then stopped.The image was attempted to be repeated and the same error occurred.The patient was moved from one ct into another where we could complete the exam.The machine was working fine all day until this error.While i was not around it is my understanding that the same error occurred yesterday around the same time and service came in to look at the machine but could not duplicate the error but could see it in the log.We were told it was ok the use the machine and a new part was ordered with plans of replacing it.Siemens will be contacted that the same error occurred and to come in about fixing it.Manufacturer response for ct scanner, somatom sensation 64/cardiac 64 (per site reporter).According to the siemens technician's field reports the foc (or field-orientated control) board was the part that had stopped working and once it was replaced with the specific d514/foc board, the machine began functioning as normal again.It is unclear in all field reports submitted by siemens as to what could possibly cause this malfunction.This incident caused several instances of patient care delay.

• Brand Name: SOMATOM SENSATION 64
• Type of Device: SYSTEM, X-RAY, TOMOGRAPHY, COMPUTED
• Manufacturer (Section D): SIEMENS MEDICAL SOLUTIONS USA, INC.; 40 liberty boulevard; mailcode: 65-1a; malvern PA 19355
• MDR Report Key: 8296726
• MDR Text Key: 134738891
• Report Number: 8296726
• 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: 01/16/2019

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 Operator: Other
• Device Model Number: SOMATOM SENSATION 64/CARDIAC 64
• 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: 01/16/2019
• Event Location: Hospital
• Date Report to Manufacturer: 02/01/2019
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 02/01/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 22265 DA