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

Model Number	11061620
Medical Device Problem Code	Inadequate or Insufficient Training (1643)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	04/27/2021
Type of Reportable Event	Death
Additional Manufacturer Narrative
Reporting facility phone number is: (b)(4).Siemens conducted a thorough technical investigation of the reported event.The root cause was clearly determined to have been an unintentional user error.There are several methods to reduce the tube load, all of which should be known to trained users (e.G enable autokv, reduce entries for auto range, decrease eff.Mas, decrease kv, and others).Siemens could not identify a system malfunction, nor a lack in usability.Based on this conclusion, no remedial action is deemed necessary.
Event or Problem Description
It was reported to siemens that a planned ct examination of an emergency patient from the facility icu was not possible because the ct could not be started due to the calculated tube cooling wait time.The patient health status was critical.The user reported that the ct scan was planned one week earlier but was postponed due the patient's condition and lack of transportation capability.A significant delay in diagnosis (1.5 hours) was associated with the tube cooling wait time warning.After the user contacted technical support, the scan was able to be completed.The user did not allege a product malfunction.Unfortunately, the patient passed away in the icu at an unknown time after the scan on (b)(6) 2021.The reported event occurred in (b)(6).

• Brand Name: SOMATOM GO.UP
• Common Device Name: SYSTEM, X-RAY, TOMOGRAPHY, COMPUTED
• Manufacturer (Section D): SIEMENS HEALTHCARE GMBH; siemenstrasse 1; forchheim, 91301 ; GM 91301
• MDR Report Key: 11863495
• Report Number: 3004977335-2021-78442
• Device Sequence Number: 3790007
• Product Code: JAK
• UDI-Device Identifier: 04056869051314
• UDI-Public: 04056869051314
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K200524
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 05/21/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Model Number: 11061620
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/27/2021
• Initial Report FDA Received Date: 05/21/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Death
• Patient Age: 47 YR