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

Model Number 10431700

Device Problem Unexpected Shutdown (4019)

Patient Problem Insufficient Information (4580)

Event Date 02/15/2022

Event Type  Death  

Manufacturer Narrative

Siemens has initiated a technical investigation of the reported event.Siemens requested that the defective x-ray tube be returned for a detailed technical investigation.A supplemental report will be submitted upon its completion.

Event Description

It was reported to siemens that during a patient procedure on (b)(6) 2022 at 5:23 pm, the ct scanner malfunctioned.The patient, a (b)(6) male, had received 90ml of contrast media (omnipaq 300) on the table with a three phase scan planned.During the second phase the user reported that the scan aborted.The user stated that they replanned/restarted the scan, but the scan aborted again.When this occurred, the issue was reported to siemens service.The system was repaired by replacing the x-ray tube.Siemens was later informed that the patient suffered from advanced stage cancer and had passed away later during the evening of (b)(6) 2022, or during the early morning on (b)(6) 2022.The exact date and time of the patient's death is unknown to siemens.The patient had metastatic pancreatic cancer, a perforated bladder, and blood clots in his lungs.Siemens asked if the failed scan could have contributed to the patient's death and was told that it was not clear as the patient was very ill, but not acquiring the data may have contributed.The scan was requested to see if there was evidence of a bleed, and the acquired data didn't show any.It is currently unknown if the scanner caused or contributed to the event.The reported event occurred in the (b)(6).

Manufacturer Narrative

Siemens completed the technical investigation of the reported event.The initial evaluation of the complaint x-ray tube did not show any conspicuous faults; however, testing reviewed that the focus had degraded.Inspection of the radiation exit tube revealed the presence of a particle, which led to the image artifacts.Inspection of the vacuum tube exhibited a deformed emitter and a reduced distance between the emitter and focal head.This led to a high voltage flash over, as confirmed by traces of this event at the edges of the focal head.In accordance with these findings, the remote data presented both side-arching accompanied by scan aborts just before the tube replacement.The root cause of the event is attributed to the deformed emitter and the presence of the particle, degraded the image quality.The complaint issue and root cause are rated as an isolated component failure.The material consumption in relation to the installed base is monitored by the capa process.Material consumption values for the last three (3) months are provided in the following for material number 11270277 - straton mx: - february 2022: 2.7% - january 2022: 2.36%, - december 2021: 2.21% no further investigation within the complaint process is necessary.

• Brand Name: SOMATOM DRIVE
• Type of Device: SYSTEM, X-RAY, TOMOGRAPHY, COMPUTED
• Manufacturer (Section D): SIEMENS HEALTHCARE GMBH; siemenstrasse 1; forchheim, 91301 ; GM 91301
• Manufacturer (Section G): SIEMENS HEALTHCARE GMBH; siemenstrasse 1; forchheim, 91301 ; GM 91301
• Manufacturer Contact: rebecca tudor ; 40 liberty blvd.; 65-1a; malvern, PA 19355 ; 4843234198
• MDR Report Key: 13634370
• MDR Text Key: 286352651
• Report Number: 3004977335-2022-16785
• Device Sequence Number: 1
• Product Code: JAK
• UDI-Device Identifier: 04056869006970
• UDI-Public: 04056869006970
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: K190578
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Other
• Remedial Action: Replace
• Type of Report: Initial,Followup
• Report Date: 06/02/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/01/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 10431700
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 06/02/2022
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Outcome(s): Death
• Patient Age: 49 YR
• Patient Sex: Male