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

Model Number	10046799
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Death (1802); Hypersensitivity/Allergic reaction (1907)
Date of Event	02/23/2021
Type of Reportable Event	Death
Additional Manufacturer Narrative
Initial reporter's telephone number is: (b)(6).Siemens has initiated a detailed technical investigation of the reported event.As of the date of this report, siemens does not have any evidence of a device malfunction and there was no allegation of device malfunction made by the customer.A supplemental report will be submitted upon the completion of the investigation.
Event or Problem Description
It was reported to siemens that a patient died on the somatom scope ct table.The scan had not yet been started when the patient event occurred.Additional information has been requested by siemens but has not yet been received as of the date of this report.The customer did not allege any malfunction of the ct system, therefore, this report is being submitted with an abundance of caution.The reported event occurred in (b)(6).
Additional Manufacturer Narrative
A2, a3, a4: patient information received and reported.B5: additional event information received and reported.Siemens completed the technical investigation of the reported event and received additional event and patient information.The investigation concluded that there was no device malfunction and the ct system performed as specified.The death of the patient was not related to the ct system.It was reported to siemens that the patient had a strong adverse reaction to the injected contrast media before the ct scan was started.No further action by siemens is warranted at this time.
Event or Problem Description
Additional information received.The patient had a strong adverse reaction to the injected contrast media before the ct scan was started.

• Brand Name: SOMATOM SCOPE POWER (DE)
• Common Device Name: SYSTEM, X-RAY, TOMOGRAPHY, COMPUTED
• Manufacturer (Section D): SIEMENS HEALTHCARE GMBH; siemenstrasse 1; forchheim, 91301 ; GM 91301
• MDR Report Key: 11423133
• Report Number: 3004977335-2021-70384
• Device Sequence Number: 14263664
• Product Code: JAK
• UDI-Device Identifier: 04056869013053
• UDI-Public: 04056869013053
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• 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): 03/22/2021

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?: No
• Operator of Device: Health Professional
• Device Model Number: 10046799
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 02/23/2021
• Supplement Date Received by Manufacturer: 03/22/2021
• Initial Report FDA Received Date: 03/05/2021
• Supplement Report FDA Received Date: 03/23/2021
• 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: 86 YR
• Patient Weight: 46