MAUDE Adverse Event Report: SIEMENS HEALTHINEERS AG CIOS ALPHA; INTERVENTIONAL FLUOROSCOPIC X-RAY SYSTEM

Model Number	10308191
Medical Device Problem Code	Computer Operating System Problem (2898)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/25/2024
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
It was reported to siemens that a malfunction occurred while operating the cios alpha system.During an emergency procedure, the user reported that the imaging system computer could not be turned on after system power on.The procedure was continued and completed on an alternate system.We are unaware of any impact to the state of health of the patient involved.Siemens has requested additional information in order to conduct an investigation of the reported event.
Additional Manufacturer Narrative
The investigation was performed by system experts using the complaint description, maintenance and service reports, system history, and system log files.As the customer did not allow siemens onsite to service the system, a root cause analysis was limited.As per the information received from the customer the uninterruptible power supply (ups) had an issue.The third-party engineer repaired the ups and the system recovered.The ups supplies voltage to the imaging system and the left-hand monitor until the system switches off completely after the power plug is disconnected.As soon as the main supply is restored, the battery of the ups is recharged.As a preventive maintenance, it's recommended an initial replacement after 42 months during full maintenance and thereafter every 48 months during regular maintenance.The spare parts should be used as recommended by siemens.In this way, siemens can ensure the quality support needed in each case and a subsequent coverage of the quality of the system.The occurrence rate of the error pattern was checked.A possible error accumulation or even a systematic error, which leads to a corrective action of the installed base, could not be determined by the investigation.Recommendations provided to the customer: the operator/customer is responsible for any risks associated with the use of system modifications not approved by siemens.This is also mentioned in the operator manual "safety chapter." original accessories: for safety reasons, only approved original accessories or non-siemens accessories approved by siemens healthineers ag, may be used for this product.The operator is liable for any risks associated with the use of accessories not approved by siemens.The use of accessories that do not comply with the safety requirements of this equipment can reduce the safety of the entire system.".
Event or Problem Description
A patient was admitted for an acute heart attack case and scheduled for an arteriogram.An arteriogram is an imaging test that uses x-rays and a special dye to visualize the inside of arteries, veins, and heart chambers.This procedure is used to look for changes in the blood vessels such as blockages, etc.During the scheduled arteriogram, the system had a malfunction and could not release x-ray which resulted in the patient being transported to another hospital to complete the procedure.No health consequences were reported as a result of this event.

• Brand Name: CIOS ALPHA
• Common Device Name: INTERVENTIONAL FLUOROSCOPIC X-RAY SYSTEM
• Manufacturer (Section D): SIEMENS HEALTHINEERS AG; siemensstrasse 1 or; rittigfeld 1; forchheim 91301 ; GM 91301
• Manufacturer (Section G): SIEMENS HEALTHINEERS AG; siemensstrasse 1 or; rittigfeld 1; forchheim 91301 ; GM 91301
• Manufacturer Contact: marion mints ; 40 liberty blvd; malvern, PA 19355 ; 4843231632
• MDR Report Key: 20608438
• Report Number: 3004977335-2024-00130
• Device Sequence Number: 18125209
• Product Code: OWB
• UDI-Device Identifier: 04056869009032
• UDI-Public: (01)04056869009032
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K210055
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Y
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 11/25/2024

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: 10308191
• Device Catalogue Number: 10308191
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/26/2024
• Supplement Date Received by Manufacturer: 11/25/2024
• Initial Report FDA Received Date: 11/05/2024
• Supplement Report FDA Received Date: 11/25/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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