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

Model Number	11061620
Medical Device Problem Code	Inaudible or Unclear Audible Prompt/Feedback (2283)
Health Effect - Clinical Code	Hypersensitivity/Allergic reaction (1907)
Date of Event	04/29/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Siemens has initiated a technical investigation of the reported event to identify the root cause of the audio system disturbance.A supplemental report will be filed upon investigation completion.
Event or Problem Description
It was reported to siemens that after injection of a contrast medium during a routine ct scan, the patient started to choke on the patient table of the somatom system.Over time, the patient's condition deteriorated further.The patient required cardiopulmonary resuscitation to revive him.The situation appeared to be a serious allergic reaction to the contrast medium.The patient was stabilized without any permanent health consequences.The user alleged that the intercom system used to communicate with patients during examination, was emitting noisy feedback during the examination, and disturbed communication between the user and the patient.The user reported the communication interference may have contributed to the user missing the first signs of the patient's allergic reaction and distress.The reported event occurred in (b)(6).
Additional Manufacturer Narrative
Siemens completed the technical investigation of the reported event.The investigation identified a sporadic problem with the firmware of the audio algorithm library.The implementation of the solution is planned for the installation of service pack sp05 for software version va30a.As a workaround, the customer was instructed to restart the system and enable the hear button at the control box once the system has been restarted.The noise can be identified immediately after the restart before the patient examination.In some cases, a second restart may become necessary to temporarily solve the issue.Furthermore, there is no direct relationship between the contrast media reaction of the patient and the malfunction of the intercom system.

• Brand Name: SOMATOM GO.UP
• Common Device Name: SYSTEM, X-RAY, TOMOGRAPHY, COMPUTED
• MDR Report Key: 11886039
• Report Number: 3004977335-2021-79208
• Device Sequence Number: 3632883
• Product Code: JAK
• UDI-Device Identifier: 04056869051314
• UDI-Public: 04056869051314
• Combination Product (Y/N): N
• Initial Reporter Country: PE
• 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,Followup
• Report Date (Section B): 10/13/2021

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?: Yes
• Operator of Device: Health Professional
• Device Model Number: 11061620
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 04/29/2021
• Supplement Date Received by Manufacturer: 10/12/2021
• Initial Report FDA Received Date: 05/26/2021
• Supplement Report FDA Received Date: 10/14/2021
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 40 YR
• Patient Weight: 75