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

Model Number 10742326

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Cardiac Arrest (1762)

Event Date 09/01/2021

Event Type  Death  

Manufacturer Narrative

Asked why the siemens local application specialist did not recommend the performance of defibrillation of the patient while the patient was on the ct patient table.The customer did not allege a device malfunction.From the r&d point of view, siemens does not recommend defibrillation while the patient is on the table of the ct table, because the table has not been tested for this use.Siemens does not expect any damage to the system but cannot guarantee the proper operation of the system after defibrillation.The final decision regarding defibrillator use, however, is always at the discretion of the user.According to the system instruction for use (print no.Hc-c2-058.621.10.02.02, page 101): "use of defibrillator" warns that "patient injury (burn) and destroying the ecg unit [are possible]"."the ct plate is grounded.Follow the instructions for use of the defibrillator before using it." a general design issue was not identified.The reported system did not cause or contribute to the death of the patient.No further action is warranted at this time.If additional event and patient information is provided to siemens, a supplemental report will be filed.

Event Description

It was reported to siemens that a (b)(6), female patient went into cardiac arrest during a ct examination using the somatom force system.There was indecision on behalf of the clinical team present during the event regarding defibrillation of the patient who was still on the ct table.Facility staff contacted the siemens service center for assistance while the patient's health status was critically declining.The patient has since expired.Additional details regarding the event were not reported to siemens.The reported event occurred in (b)(6).

• Brand Name: SOMATOM FORCE
• 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 ; 6104486484
• MDR Report Key: 12553761
• MDR Text Key: 274000775
• Report Number: 3004977335-2021-96624
• Device Sequence Number: 1
• Product Code: JAK
• UDI-Device Identifier: 04056869006956
• UDI-Public: 04056869006956
• Combination Product (y/n): N
• Reporter Country Code: AS
• PMA/PMN Number: K190578
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 09/29/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/30/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 10742326
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 09/08/2021
• 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: 103 YR