MAUDE Adverse Event Report: SIEMENS SHANGHAI, MEDICAL EQUIPMENT LTD. SOMATOM GO.NOW; SYSTEM, X-RAY, TOMOGRAPHY, COMPUTED

Model Number 11061613

Device Problem Computer Software Problem (1112)

Patient Problem Insufficient Information (4580)

Event Date 11/10/2022

Event Type  malfunction  

Manufacturer Narrative

Siemens is conducting a thorough investigation of the reported events.As this event is under investigation, a root cause has not yet been determined.A supplement report will be filed upon completion of the investigation.

Event Description

It was reported to siemens that an adverse event and malfunction occurred while operating the somatom go.Now ct system.On (b)(6) 2022, the ct scanner caused a delay in diagnosis to an intubated 50-year-old female patient.During positioning of the patient on the table for a chest exam, the ct software hung up and the patient was taken off the table to restart the ct system.After the patient was removed from the exam table, the patient collapsed and was immediately transferred to the icu.The examination was not repeated.It was reported to siemens on (b)(6) 2022, that the patient had passed away.Currently, there is no correlation between the system malfunction and the death of the patient.Siemens has requested additional information in order to conduct an investigation of the reported event.

Manufacturer Narrative

H10: manufacturer narrative: siemens completed the technical investigation of the reported event.Based on the customer service report the customer claimed the system froze when the patient was on the patient table before scan execution at about 5:20 pm on (b)(6) 2022.The customer had to restart the gantry and the system recovered after that.However, this was a severe patient on a ventilator and in an intubated condition.On (b)(6) 2022, siemens was informed that the patient had unfortunately passed away.The reported time stamp of system freeze was at about 5:20 pm, on (b)(6) 2022.However, after siemens checked the save log, siemens could not find a system log between 4:35 pm and 7:42 pm.According to the logs, the system started at 7:42:16 pm.The last system performance log at 4:34:17 pm didn't show any software abnormalities and did not show there was any software errors before this log timestamp.The log showed the system had been working well after the system was started at 7:42 pm on (b)(6) 2022 up to the date of the investigation completion on december 22, 2022.Siemens ssme had requested more information for additional investigation, however, based on information from the siemens customer service engineer, it is confirmed with an official email from the customer (b)(6) hospital) that the customer had conducted an internal hospital investigation and discovered that the reported ct scanner machine played no role in the patient collapse incident.The hospital refused to share any other information including patient-related information with siemens due to data privacy and requested siemens to close the investigation.Based on the information received, the reported system issue was not related to the reported incident or patient outcome.This complaint was closed due to lack of information.H11 corrected data: the mfr.Report number should have been 3003202425-2022-52792 to reflect the device manufacturer as being: siemens shanghai, medical equipment ltd.278 zhou zhu rd.Shanghai 201318, chn.Since the initial report, submitted on december 12, 2022 was reported under mfr.Report number 3004977335-2022-52792, siemens has submitted this supplemental report under the same number as the initial to avoid confusion.B3: date of event was november 10, 2022.D3, g1: siemens shanghai, medical equipment ltd.278 zhou zhu rd.Shanghai 201318, chn.

• Brand Name: SOMATOM GO.NOW
• Type of Device: SYSTEM, X-RAY, TOMOGRAPHY, COMPUTED
• Manufacturer (Section D): SIEMENS SHANGHAI, MEDICAL EQUIPMENT LTD.; 278 zhou zhu rd.; rittigfeld 1; shanghai, 20131 8; CH 201318
• Manufacturer (Section G): SIEMENS SHANGHAI, MEDICAL EQUIPMENT LTD.; 278 zhou zhu rd.; rittigfeld 1; shanghai, 20131 8; CH 201318
• Manufacturer Contact: rebecca tudor ; 40 liberty blvd.; 65-1a; malvern, PA 19355 ; 4843234198
• MDR Report Key: 15959005
• MDR Text Key: 308387437
• Report Number: 3004977335-2022-52792
• Device Sequence Number: 1
• Product Code: JAK
• UDI-Device Identifier: 04056869051291
• UDI-Public: 04056869051291
• Combination Product (y/n): N
• Reporter Country Code: IN
• PMA/PMN Number: K211373
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Health Professional,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 12/27/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/12/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 11061613
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/22/2022
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 50 YR
• Patient Sex: Female