MAUDE Adverse Event Report: SIEMENS HEALTHCARE GMBH CIOS ALPHA; IMAGE-INTENSIFIED FLUOROSCOPIC X-RAY SYSTEM

Model Number	11105200
Medical Device Problem Code	Output Problem (3005)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/13/2022
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.Internal id # (b)(4).
Event or Problem Description
It was reported to siemens that a malfunction occurred while operating the cios alpha system.During an interventional procedure with a patient in critical condition, the user reported that the brake on the system could not be released.The clinical procedure had to be terminated.Siemens has requested additional information in order to conduct an investigation of the reported event.However, additional information was received that the involved patient had not been injured.The reported event in japan.
Additional Manufacturer Narrative
H10: siemens completed the investigation of the reported event.The investigation was performed based on expert discussions (considering complaint description, customer service reports, system history, c-part).During an interventional procedure, the c-arm stand brake could not be released.The procedure was continued and finished using the imperfect system, while the system was moved with the help of three people.The patient was not injured due to the event.The onsite service intervention revealed a malfunctioning brake cable rocker, which was exchanged as part of service activity.The brake cable rocker enables the wheels to lock and unlocked while the user activates/deactivates the brakes.According to the available information, the typical locking noise could no longer be heard after very little use and unlocking was prevented.This error could be simulated with the malfunctioning part in a factory test.Detailed investigation of the malfunctioning part revealed that one dimension was out of tolerance (root cause).Inventories were reviewed.No further problems were found.Therefore, this issue is considered an isolated case.The affected part was replaced as part of service activity, which resolved the problem.The spare parts consumption was checked.Any accumulation of faults or even a possible general fault that would require corrective action of the installed base could not be determined by the investigation.The incident was not classified as an adverse event after detailed investigation, because neither serious injury, death nor an unexpected or prolonged hospitalization of the patient or any other person occurred or could be expected.The corresponding probability according to the risk analysis is in the range of inconceivable.Internal id (b)(6).

• Brand Name: CIOS ALPHA
• Common Device Name: IMAGE-INTENSIFIED FLUOROSCOPIC X-RAY SYSTEM
• Manufacturer (Section D): SIEMENS HEALTHCARE GMBH; siemenstrasse 1 or; rittigfeld 1; forchheim, 91301 ; GM 91301
• Manufacturer (Section G): SIEMENS HEALTHCARE GMBH-AT; siemensstr. 1 or rittigfeld 1; rittigfeld 1; forchheim, 91301 ; GM 91301
• Manufacturer Contact: rebecca tudor ; 40 liberty blvd.; 65-1a; malvern, PA 19355 ; 4843234198
• MDR Report Key: 15393267
• Report Number: 3004977335-2022-38210
• Device Sequence Number: 14716748
• Product Code: OWB
• UDI-Device Identifier: 04056869153490
• UDI-Public: 04056869153490
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K181560
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,User Facility,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 11/10/2022

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: 11105200
• 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: 09/06/2022
• Supplement Date Received by Manufacturer: 11/10/2022
• Initial Report FDA Received Date: 09/09/2022
• Supplement Report FDA Received Date: 11/10/2022
• 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: Other
• Patient Sex: Unknown