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

Model Number	11105200
Medical Device Problem Codes	Electrical /Electronic Property Problem (1198); Unintended Electrical Shock (4018)
Health Effect - Clinical Code	Electric Shock (2554)
Date of Event	08/31/2022
Type of Reportable Event	Serious Injury
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 upon completion of the investigation.Internal id # (b)(4).
Event or Problem Description
It was reported to siemens that an incident occurred with the cios alpha system.The user received an electric shock while removing the x.10 connector.The operator complained of pain in his forearm and was examined in the er.The operator did not suffer any injuries and was found to be in good health.Siemens has requested additional information in order to conduct an investigation of the reported event.The reported event occurred in switzerland.
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, and cc-part analysis).The operator reported an electric shock when removing the trolley chasis (tc) cable.Although the system was switched off, the system was still connected to the mains power supply.The customer was immediately checked.The operator is in good health after the incident.Customer service engineer (cse) was onsite and could not reproduce the incident.However, investigations showed that the tc cable was worn out.The mains cable was also damaged.Nevertheless, none of these issues can contribute to an electric shock from a technical point of view.A possible electric shock from the pins of the site where the tc cable is connected has been considered in the past.Multiple safety measures were implemented, and no issues were reported since until this occurrence.Therefore, it remains unclear how an electric shock could happen.As reproduction of the issue is not possible and no other incident was known, a possibility that this issue was caused by an electrical discharge cannot be excluded.The tc and mains cables were exchanged by the cse.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.No corrective action is necessary.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, even if the incident recurs.Internal id# (b)(4).

• 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: 15412481
• Report Number: 3004977335-2022-42963
• Device Sequence Number: 12172383
• Product Code: OWB
• UDI-Device Identifier: 04056869153490
• UDI-Public: 04056869153490
• Combination Product (Y/N): N
• Initial Reporter Country: SZ
• 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): 11/16/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• 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: 09/01/2022
• Supplement Date Received by Manufacturer: 11/14/2022
• Initial Report FDA Received Date: 09/13/2022
• Supplement Report FDA Received Date: 11/16/2022
• 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