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

Model Number 11330001

Device Problem Use of Device Problem (1670)

Patient Problem Sepsis (2067)

Event Date 05/02/2022

Event Type  Death  

Event 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).

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
• 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: 14489605
• MDR Text Key: 292564058
• Report Number: 3004977335-2022-26477
• Device Sequence Number: 1
• Product Code: JAK
• UDI-Device Identifier: 04056869231044
• UDI-Public: 04056869231044
• Combination Product (y/n): N
• Reporter Country Code: IS
• PMA/PMN Number: K211373
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 05/24/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/24/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 11330001
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 05/02/2022
• 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 Sex: Male