MAUDE Adverse Event Report: SIEMENS HEALTHCARE GMBH-CT SOMATOM SENSATION 64; SYSTEM, X-RAY, TOMOGRAPHY, COMPUTED

Model Number 8377520

Device Problem Mechanical Problem (1384)

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

Event Date 06/01/2022

Event Type  malfunction  

Manufacturer Narrative

Siemens has completed an investigation of the reported event.The system has reached end of service and end of delivery since december 31, 2019.The customer did not call siemens service for investigation of the reported issue.A third party company (ge) was contacted for system maintenance.The third party replaced the mcu (master control unit) twice.More details of the issue and service actions were requested but not provided.According to the available information, no general design issue has been determined.

Event Description

It was reported to siemens that a malfunction occurred while operating the somatom sensation 64 ct system.The customer reported that the scanning of a patient aborted twice on (b)(6), 2022.The customer scanned an adrenal protocol on the patient that began with a non-contrast scan of the abdomen and pelvis and the system aborted after trying to acquire one image.The customer reloaded the scan and the system aborted after a short series of images.The patient was than rescanned on another ct system.Besides the additional x-ray dose, no negative health consequences were reported.

• Brand Name: SOMATOM SENSATION 64
• Type of Device: SYSTEM, X-RAY, TOMOGRAPHY, COMPUTED
• Manufacturer (Section D): SIEMENS HEALTHCARE GMBH-CT; siemensstr. 1 -or-; rittigfeld 1; forchheim, germany 91301 ; GM 91301
• Manufacturer (Section G): SIEMENS HEALTHCARE GMBH-CT; siemensstr. 1 -or-; rittigfeld 1; forchheim, germany 91301 ; GM 91301
• Manufacturer Contact: meredith adams ; 40 liberty blvd.; malvern, PA 19355 ; 4843231631
• MDR Report Key: 15162872
• MDR Text Key: 297532956
• Report Number: 3004977335-2022-35873
• Device Sequence Number: 1
• Product Code: JAK
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K142955
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: User Facility
• Reporter Occupation: Other
• Remedial Action: Repair
• Type of Report: Initial
• Report Date: 08/04/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/04/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 8377520
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 07/12/2022
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1