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

Model Number 8098027

Device Problem Patient Data Problem (3197)

Patient Problem Intracranial Hemorrhage (1891)

Event Date 11/07/2020

Event Type  Death  

Manufacturer Narrative

Initial reporter's telephone number is: (b)(6).Siemens has initiated a technical investigation of the reported event.The root cause has not yet been identified.A supplemental report will be submitted upon the completion of the investigation.

Event Description

It was reported to siemens that during the contrast triggered ct scan of an emergency patient, the examination aborted.The user reported that during the triggered scan they encountered data transmission problems that caused the scan to abort.According to the hospital's head of department, the patient's health status was already very poor before they started the ct scan (intracerebral hemorrhage).The patient had received 70ml of omnipag 300.The scan needed to be repeated; however, the second scan was not repeated due to the deterioration of the patient's heath.After the initial procedure attempt, the patient needed to be intubated and died 90 minutes later.It cannot be determined at this time whether the delay of the ct procedure contributed to the deterioration in the patient's state of health.The reported event occurred in the (b)(6).

Manufacturer Narrative

Siemens completed the technical evaluation of the reported complaint issue.The reported technical issue did not recur.The system has been inspected onsite and the available logfiles were investigated in detail.Despite the investigation efforts, the root cause could not be identified with the available information.A timing issue found in the logfile points to the xgs control box.The local service engineer has been advised to replace the xgs control box proactively.The material consumption in relation to the installed base is monitored by the capa process.Values for the last three months for material number(b)(4)- service part matrix xgr box are as follows: (b)(4) 2020,(b)(4); (b)(4) 2020,(b)(4); (b)(4)2020,(b)(4).No general design issue was identified.

• Brand Name: SOMATOM DEFINITION AS
• Type of Device: SYSTEM, X-RAY, TOMOGRAPHY, COMPUTED
• Manufacturer (Section D): SIEMENS HEALTHCARE GMBH; siemenstrasse 1; forchheim, 91301 ; GM 91301
• MDR Report Key: 10860084
• MDR Text Key: 216842188
• Report Number: 3004977335-2020-54619
• Device Sequence Number: 1
• Product Code: JAK
• UDI-Device Identifier: 04056869003665
• UDI-Public: 04056869003665
• Combination Product (y/n): N
• PMA/PMN Number: K190578
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 12/28/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/18/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 8098027
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 12/22/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Death
• Patient Age: 55 YR