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

Model Number	10308192
Medical Device Problem Code	Mechanical Jam (2983)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/09/2021
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 while operating the cios fusion system.The user reported that the c-arm couldn't move or lift and reported an exposure failure sporadically.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 motor control unit (mcu) was defective and was replaced.Examination of the board revealed that capacitor c181 was mechanically damaged.According to experts, improper handling during a technical intervention is the most likely cause.In this context, it remains to be noted that the device was technically modified, i.E., changed without permission, apparently with parts that are neither specified nor approved by siemens.According to the siemens service engineer, he found the system modified with a non-siemens wireless exposure button.Siemens cannot be held responsible for such interventions.Therefore, the user manual of the cios fusion states, among other things, as follows: chapter 2.3.3 installation, repair: modifications of or additions to the product must be made in accordance with the legal regulations and generally accepted engineering standards.The manufacturer, siemens, cannot accept responsibility for the safety features and for the reliability and performance of the equipment if: the product is used in a manner other than that specified in the operator manual installation, upgrades, readjustments, modifications, or repairs are performed by personnel not contracted and authorized by siemens components affecting safe operation of the product are not replaced by original spare parts in the event of a malfunction the electrical wiring in the room containing the system does not meet the specifications of din vde 0107 or the corresponding local regulations chapter 2.3.4 original accessories: for safety reasons, only approved original accessories or non-siemens accessories approved by siemens healthcare gmbh, may be used for this product.The operator is liable for any risks associated with the use of accessories not approved by siemens.Caution: inappropriate accessories.The use of accessories that do not comply with the safety requirements of this equipment can reduce the safety of the entire system.Use only original siemens accessories or accessories approved by siemens.The affected part has been exchanged by the local service organization and the error has not been reported again.Apart from the unauthorized changes mentioned above, no possible general error that would require corrective action of the installed base could be identified 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 FUSION
• Common Device Name: INTERVENTIONAL FLUOROSCOPIC X-RAY SYSTEM
• Manufacturer (Section D): SIEMENS HEALTHCARE GMBH; siemensstr. 1; forchheim, germany 91301 ; GM 91301
• MDR Report Key: 12083915
• Report Number: 3004977335-2021-84605
• Device Sequence Number: 14515629
• Product Code: OWB
• UDI-Device Identifier: 04056869009056
• UDI-Public: 04056869009056
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K153244
• 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): 06/29/2021

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: 10308192
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 06/10/2021
• Supplement Date Received by Manufacturer: 08/19/2021
• Initial Report FDA Received Date: 06/29/2021
• Supplement Report FDA Received Date: 08/19/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1