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

Model Number	10308191
Medical Device Problem Code	No Display/Image (1183)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/19/2020
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.
Event or Problem Description
It was reported to siemens that a malfunction occurred while operating the cios alpha system.During a procedure, the user reported that no image was displayed on the live monitor.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
Siemens has completed an investigation of the reported event.The root cause was determined to be a hardware error.The investigation showed that the problem was caused by a temporary hardware problem.Troubleshooting by the service technician on site revealed that one pin of the monitor's pluggable power supply was slightly bent and had insufficient electrical contact.As a result, the system experienced temporary image failure.The technician was able to re-establish contact during his on-site visit and the error has not been reported again.It was not necessary to replace any parts.A possible general error which would require corrective measures 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: INTERVENTIONAL FLUOROSCOPIC X-RAY SYSTEM
• Manufacturer (Section D): SIEMENS HEALTHCARE GMBH- AT; siemensstrasse 1; forchheim, germany 91301 ; GM 91301
• MDR Report Key: 10747166
• Report Number: 3004977335-2020-51881
• Device Sequence Number: 11544623
• Product Code: OWB
• UDI-Device Identifier: 04056869009032
• UDI-Public: 04056869009032
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• 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: company representative,foreig
• Initial Reporter Occupation: Other
• Remedial Action: Repair,Inspection
• Type of Report: Initial,Followup
• Report Date (Section B): 10/28/2020

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
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 10/19/2020
• Supplement Date Received by Manufacturer: 12/07/2020
• Initial Report FDA Received Date: 10/28/2020
• Supplement Report FDA Received Date: 12/07/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1