MAUDE Adverse Event Report: SIEMENS HEALTHCARE GMBH SOMATOM DEFINITION AS; JAK

Model Number 8098027

Device Problem Use of Device Problem (1670)

Patient Problem Insufficient Information (4580)

Event Date 05/02/2022

Event Type  Injury  

Event Description

It was reported to siemens that the ct scan of a polytrauma patient was not possible.The patient was hospitalized after a fall from a window (height unknown) and an emergency diagnosis was need on (b)(6) 2022, at 5:53am.The first topogram (low dose overview scan) was marked in yellow (warning that scanning cannot continue, and changes are needed in the protocol), so it was not possible to start the volume scan.The customer repeated the topogram six (6) times to obtain the clearance for the urgently needed head scan a at 6:09am.The scan was successfully completed.The patient was on the ct table for approximately 20 minutes.A device malfunction was not reported.An abdominal scan was also needed but was not started because the rescue service decided to move the patient to another hospital.The patient unfortunately expired at the second hospital.The reported event occurred in (b)(6).

Manufacturer Narrative

Although a device malfunction was not reported, siemens initiated a technical investigation of the reported event.A siemens application specialist reviewed the case and suspects a use error occurred during this hectic emergency situation.Siemens will investigate the log files associated with the event and submit a supplemental report if a device design or labeling issue is identified.

Manufacturer Narrative

Siemens has completed an investigation of the reported event.Assessment does not indicate a system failure or malfunction and no non-conformity was identified.The ct system works as specified.The tilt of the spiral scan was set outside the collision limits.The customer was advised to set the tilt of the gantry to a valid value for the current scan mode.

• Brand Name: SOMATOM DEFINITION AS
• Type of Device: JAK
• Manufacturer (Section D): SIEMENS HEALTHCARE GMBH; siemenstrasse 1; forchheim, 91301 ; GM 91301
• Manufacturer (Section G): SIEMENS HEALTHCARE GMBH-CT; siemensstr. 1; forchheim, germany 91301 ; GM 91301
• Manufacturer Contact: meredith adams ; 40 liberty blvd.; 65-1a; malvern, PA 19355 ; 4843231631
• MDR Report Key: 14345392
• MDR Text Key: 291302446
• Report Number: 3004977335-2022-26598
• Device Sequence Number: 1
• Product Code: JAK
• UDI-Device Identifier: 04056869003665
• UDI-Public: 04056869003665
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: K190578
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Other
• Remedial Action: Inspection
• Type of Report: Initial,Followup
• Report Date: 05/10/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/10/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 8098027
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 06/03/2022
• 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 Age: 49 YR
• Patient Sex: Male