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

Model Number 10430603

Device Problem Circuit Failure (1089)

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

Event Date 08/27/2022

Event Type  Injury  

Event Description

It was reported to siemens that a malfunction occurred prior to operating the somatom definition flash ct system.On (b)(6) 2002, two children (15 months and 7 years) were planned for examination.A system malfunction occurred and the examination could not be performed.The siemens service engineer checked the system onsite and found two defective fuses on the pdr component (power distribution rotating) and replaced them.Further checks were performed, and a defective tube was also identified.The tube was replaced on (b)(6) 2022, and the system was brought back to clinical operation.According to information received, both patients were rescanned and are in good health condition.No negative health consequences were reported for the children associated with the reported event.

Manufacturer Narrative

Siemens has completed an investigation of the reported event.The material consumption in relation to the installed base is monitored by our capa process.The consumption for the affected component on this specific system is normal and within defined thresholds.No further investigation within the complaint process is necessary.Based on the information available, no general product design issue could be identified, and no further measures are required.This issue is rated as a service case.Therefore, this report has been submitted with an abundance of caution.

• Brand Name: SOMATOM DEFINITION FLASH
• 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: 15392235
• MDR Text Key: 299580904
• Report Number: 3004977335-2022-42881
• Device Sequence Number: 1
• Product Code: JAK
• UDI-Device Identifier: 04056869006963
• UDI-Public: 04056869006963
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: K190578
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,User Facility
• Reporter Occupation: Other
• Remedial Action: Repair
• Type of Report: Initial
• Report Date: 09/09/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/09/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 10430603
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 08/30/2022
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 7 YR