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

Model Number	10308191
Medical Device Problem Codes	Mechanical Problem (1384); Unintended Movement (3026)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/25/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Siemens is conducting a thorough investigation of the reported events.As this event is under investigation, a root cause has not yet been determined.A supplement report will be filed upon completion of the investigation.Internal id # (b)(4).
Event or Problem Description
It was reported to siemens that a vertical lift on the cios alpha systems was not working and giving error 2044/032.Additional information was provided stating that unintended movement had occurred during a diagnostic procedure.We are unaware of any impact to the state of health of the patient involved.Siemens has requested additional information to conduct an investigation of the reported event.The reported event occurred in (b)(6).
Additional Manufacturer Narrative
Siemens has completed an investigation of the reported event.The root cause was determined to be a hardware error.The extensive investigation showed that the problem was based on a temporary hardware error.After various parts were replaced on site and the fault was still not resolved, it was decided to replace the entire system and examine it in detail at the factory.At the factory, it was determined that the error was of a sporadic nature and that a contact of the cable of the vertical motor had poor contact.This led to the described error pattern from time to time.After the contact was restored, the system ran perfectly and the problem did not reoccur.The occurrence rate of the error pattern and the spare parts consumption of the affected part were checked.A possible error accumulation or even a systematic error, which would lead to a corrective action of the installed base, could not be determined by the investigation.After detailed investigation, the incident is not classified as a reportable event as neither serious injury, death nor an unexpected, prolonged hospitalization of the patient or any other person occurred or could be expected.

• Brand Name: CIOS ALPHA
• Common Device Name: IMAGE-INTENSIFIED FLUOROSCOPIC X-RAY SYSTEM
• Manufacturer (Section D): SIEMENS HEALTHCARE GMBH; siemenstrasse 1; forchheim, 91301 ; GM 91301
• MDR Report Key: 12224866
• Report Number: 3004977335-2021-88203
• Device Sequence Number: 11841748
• Product Code: OWB
• UDI-Device Identifier: 04056869009032
• UDI-Public: 04056869009032
• Combination Product (Y/N): N
• Initial Reporter Country: SF
• PMA/510(K) Number: K210055
• 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 Health Care Professional
• Remedial Action: Repair,Inspection
• Type of Report: Initial,Followup
• Report Date (Section B): 07/26/2021

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
• Initial Date Received by Manufacturer: 07/01/2021
• Supplement Date Received by Manufacturer: 10/25/2021
• Initial Report FDA Received Date: 07/26/2021
• Supplement Report FDA Received Date: 10/25/2021
• 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: Other