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

Model Number	11330001
Medical Device Problem Code	Use of Device Problem (1670)
Health Effect - Clinical Code	Sepsis (2067)
Date of Event	05/02/2022
Type of Reportable Event	Death
Event or Problem Description
It was reported to siemens that during the ct examination of an unstable, critical patient, the patient needed a cpr (cardiopulmonary resuscitation), the patient table sheet and some equipment cables got stuck in the slit between the table and tabletop, so the patient could not be pulled out of the gantry for cpr until staff member cut the sheet and the cables in order to release him.The delay was reported as "a few minutes".Due the patient's medical history, the family decided that the patient should not be resuscitated ("dnr").The patient unfortunately passed away following septic shock.This was not a result of the delay in cpr in the ct room.The reported event occurred in (b)(6).
Additional Manufacturer Narrative
Siemens evaluated the gap dimensions between the moving tabletop and the stationary portion.The gap dimensions were found to be within system the specification (less than 8 mm).Siemens did not identify a device malfunction.Remedial action was not deemed necessary for this event.

• Brand Name: SOMATOM X.CITE
• Common Device Name: 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: 14489605
• Report Number: 3004977335-2022-26477
• Device Sequence Number: 11932449
• Product Code: JAK
• UDI-Device Identifier: 04056869231044
• UDI-Public: 04056869231044
• Combination Product (Y/N): N
• Initial Reporter Country: IS
• PMA/510(K) Number: K211373
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 05/24/2022

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: 11330001
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/02/2022
• Initial Report FDA Received Date: 05/24/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Death
• Patient Sex: Male