MAUDE Adverse Event Report: SIEMENS HEALTHCARE GMBH AXIOM SENSIS COMBO; COMPUTER, DIAGNOSTIC, PROGRAMMABLE

Model Number	11007642
Medical Device Problem Code	Display or Visual Feedback Problem (1184)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/28/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Siemens is conducting a thorough investigation of the reported event.As this event is under investigation, a root cause has not yet been determined.A supplement report will be filed if additional information becomes available.
Event or Problem Description
Siemens became aware on a malfunction that occurred while operating the sensis vibe combo system.The user reported that while performing an external pacing procedure, the system stopped displaying vital signs and the screen went black.The vital signs had to monitored via the pacemaker.We have no indications of any adverse effects on the health status of the involved persons.
Additional Manufacturer Narrative
H3, h6: siemens completed the investigation of the reported issue.The investigation was performed based on expert discussions considering complaint description, customer service reports, system history, and system log files.According to the customer report, no ecg (electrocardiography) curves were displayed on the sensis system when defibrillation was applied.The log file investigation did not reveal any system issues.Grounding measurements as well as leakage currents, which were performed as part of reactive service activity, are within the tolerance limits.A test with an ecg simulator showed no problems.There is no indication for any system problem.The design of the sensis system allows to remain connected to the patient during defibrillation.Anyway, due to the discharge of a defibrillator, the real-time waveforms can be distorted or lost, which recover after some time.The reported event describes exactly the situation after defibrillation.It is also confirmed that after some time the ecg signals were displayed again.The system instruction for use contains adequate information on using defibrillator on a patient when operated together with sensis system.The complaint has been closed.

• Brand Name: AXIOM SENSIS COMBO
• Common Device Name: COMPUTER, DIAGNOSTIC, PROGRAMMABLE
• Manufacturer (Section D): SIEMENS HEALTHCARE GMBH; siemensstrasse 1 or; rittigfeld 1; forchheim 91301 ; GM 91301
• Manufacturer (Section G): SIEMENS HEALTHCARE GMBH; siemensstrasse 1; or rittigfeld 1; forchheim 91301 ; GM 91301
• Manufacturer Contact: rebecca tudor ; 40 liberty blvd., mc 65-1a; malvern, PA 19355 ; 4843234198
• MDR Report Key: 17630948
• Report Number: 3004977335-2023-00098
• Device Sequence Number: 7617850
• Product Code: DQK
• UDI-Device Identifier: 04056869010205
• UDI-Public: 04056869010205
• Combination Product (Y/N): N
• Initial Reporter Country: SZ
• PMA/510(K) Number: K150493
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 10/27/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: 11007642
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/23/2023
• Supplement Date Received by Manufacturer: 10/26/2023
• Initial Report FDA Received Date: 08/28/2023
• Supplement Report FDA Received Date: 10/27/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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: A
• Patient Sequence Number: 1
• Patient Sex: Unknown