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

Model Number	10430603
Medical Device Problem Code	Operating System Becomes Nonfunctional (2996)
Health Effect - Clinical Code	Death (1802)
Date of Event	11/24/2020
Type of Reportable Event	Death
Additional Manufacturer Narrative
Initial reporter's telephone number is: (b)(6).Siemens has initiated a technical investigation of the reported event.The root cause of the event has not yet been determined.A supplemental report will be submitted upon completion of the investigation and receipt of additional information from the reporting facility.
Event or Problem Description
It was reported to siemens on (b)(6) 2020 that a patient expired after a ct examination on (b)(6) 2020.There was a malfunction of somatom definition flash scanner which caused an approximate 20-minute delay in diagnosis.It was necessary to reboot the system twice until it was ready to scan again.The examination was completed after the 20-minute delay.The system log showed the following error: "rotation motor position timeout." it is not clear at this time if the delay in diagnosis caused or contributed to the death of the patient.Additional information from the reporting facility is pending.The reported event occurred in (b)(6).
Additional Manufacturer Narrative
Siemens completed a detailed technical investigation of the reported event.The issue has been identified and solved.After replacement of the lps (light position sensor for gantry rotor position) and the cable w350 on the 29 december 2020, the ct system is stable again.The material consumption in relation to the installed base is monitored by our capa process (values for the last 3 months see below).No further investigation within the complaint process is deemed necessary.Mat# 7741015 - lps unit - december 2020: 0,16%, november 2020: 0,16%, october 2020: 0,08%.Mat# 8902202 - w350 electrical conductor is not listed in the spare part catalogue, this cable is rarely ordered via a special "non defined spare parts" process.It has been ordered two times since 2020/01/01 until today.This cable is used in several ct scanners, the total number of globally installed systems is 9305.No general design issue has been identified.

• Brand Name: SOMATOM DEFINITION FLASH
• Common Device Name: SYSTEM, X-RAY, TOMOGRAPHY, COMPUTED
• Manufacturer (Section D): SIEMENS HEALTHCARE GMBH; siemenstrasse 1; forchheim, 91301 ; GM 91301
• MDR Report Key: 11057920
• Report Number: 3004977335-2020-57468
• Device Sequence Number: 19479470
• Product Code: JAK
• UDI-Device Identifier: 04056869006963
• UDI-Public: 04056869006963
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: K190578
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 02/09/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: 10430603
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 12/15/2020
• Supplement Date Received by Manufacturer: 02/08/2021
• Initial Report FDA Received Date: 12/22/2020
• Supplement Report FDA Received Date: 02/09/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Death
• Patient Age: 70 YR