MAUDE Adverse Event Report: SIEMENS HEALTHCARE GMBH SOMATOM PERSPECTIVE 16 (DE); SYSTEM, X-RAY, TOMOGRAPHY, COMPUTED

Model Number	10046734
Medical Device Problem Code	Output Problem (3005)
Health Effect - Clinical Code	Death (1802)
Date of Event	08/21/2020
Type of Reportable Event	Death
Additional Manufacturer Narrative
Initial reporter facility phone number: (b)(6).Siemens has initiated a technical investigation of the reported complaint.The root cause has not yet been determined.A supplemental report will be provided upon completion of the investigation.
Event or Problem Description
It was reported to siemens that during an emergency examination using the somatom perspective 16 system, the scanning procedure could not be completed, and the patient died on the ct-table.According to the head of the facility emergency department, the patient had thrown himself out of a window and fell approximately three meters before he was admitted to the hospital.The patient was unconscious, but his vital parameters were stable upon hospital emergency room admission.After the patient was positioned on the ct-table, the health status of the patient deteriorated, and the patient was intubated.Subsequently, a circulatory failure occurred, and no further resuscitation was performed due to the patient's medical history (preexisting unspecified lung and myocardial conditions).The head of the emergency department stated that the patient's prognosis was rather poor upon admission.It is not known if the system issue, that resulted in a delay in diagnosis, attributed to the patient's death.The reported event occurred in (b)(6).
Additional Manufacturer Narrative
Siemens completed a detailed technical investigation of the reported event.The root cause of the issue is that the his / ris (hospital or radiology information system) sent 2 repeated "requested procedures descriptions (dicom data tag 0032, 1060)" to ct with dicom worklist.The ct event log, for this patient / study, showed that there were 17 requested procedures registered but two were duplicates (requested procedure "ct-thoram mit km" and "ct-obere extremität handgelenk links").In the som5 sw platform the requested procedure description or requested procedure id cannot be duplicated, therefore, the examination could not be processed (completed).The ct scanner works as specified meets dicom conformance.Further investigation is not warranted at this time.If the problem reoccurs with this system, siemens will need dicom merge logs to perform a more in-depth technical investigation.

• Brand Name: SOMATOM PERSPECTIVE 16 (DE)
• Common Device Name: SYSTEM, X-RAY, TOMOGRAPHY, COMPUTED
• Manufacturer (Section D): SIEMENS HEALTHCARE GMBH; siemenstrasse 1; forchheim, 91301 ; GM 91301
• MDR Report Key: 10441580
• Report Number: 3004977335-2020-43302
• Device Sequence Number: 4059969
• Product Code: JAK
• UDI-Device Identifier: 04056869013046
• UDI-Public: 04056869013046
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K183548
• 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): 08/24/2020

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: 10046734
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 08/21/2020
• Supplement Date Received by Manufacturer: 09/17/2020
• Initial Report FDA Received Date: 08/24/2020
• Supplement Report FDA Received Date: 09/22/2020
• 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: 68 YR