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

Model Number	10308191
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/06/2021
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.
Event or Problem Description
It was reported to siemens that a malfunction occurred with the cios alpha system.The user reported a leakage of fluid from the coooing system which could potentially leak into the patient area during operation.There is no report of impact to the state of health of any patient or user 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 was performed considering complaint description, cs reports, and system history.Prior to system usage, the user noticed liquid on the detector and then called siemens service.It was found that cooling liquid was leaking from the cover of the x-ray tube onto the cover of the detector.A detailed investigation revealed that the leakage originated from the connector between the water cooler and the x-ray tube.It was a very slow leak, so no breach occurred or would have been expected to occur.According to the information given, the user came into contact with the cooling liquid.As no further information is available and no health consequences have been reported, it is assumed that the liquid was touched by the user and thus he had skin contact.Since this liquid (antifrogen n water-mixture 34% from clariant) could be only harmful if swallowed or could be harmful through prolonged or repeated exposure, further the user had most likely washed his hands after contact, health consequences are very unlikely or even impossible.The defective connector as well as all related connector sealings (o-rings) have been replaced as part of service activity.Due to material aging and weakening, the occurrence of leakage cannot be completely prevented.The occurrence rate of the identified cause has been checked and no error accumulation has been identified.The occurrence rate is below the defined threshold, therefore, no corrective action is necessary.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; forccheim, germany 91301 ; GM 91301
• Manufacturer (Section G): SIEMENS HEALTHCARE GMBH-AT; siemensstr. 1; forchheim, germany 91301 ; GM 91301
• Manufacturer Contact: meredith adams ; 40 liberty blvd.; malvern, PA 19355 ; 6104486461
• MDR Report Key: 12655372
• Report Number: 3004977335-2021-99811
• Device Sequence Number: 17263063
• Product Code: OWB
• UDI-Device Identifier: 04056869009032
• UDI-Public: 04056869009032
• Combination Product (Y/N): N
• Initial Reporter Country: NZ
• 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,Company Representative
• Initial Reporter Occupation: Other
• Remedial Action: Inspection,Repair
• Type of Report: Initial,Followup
• Report Date (Section B): 10/19/2021

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
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 10/06/2021
• Supplement Date Received by Manufacturer: 11/30/2021
• Initial Report FDA Received Date: 10/19/2021
• Supplement Report FDA Received Date: 11/30/2021
• 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
• Patient Sequence Number: 1
• Patient Sex: Unknown