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

Model Number	10308194
Medical Device Problem Code	Fail-Safe Problem (2936)
Health Effect - Clinical Code	Unspecified Tissue Injury (4559)
Date of Event	12/20/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Event was reported by a siemens employee.A customer contact name, phone number, and email were not provided, since the injury occurred to a siemens employee.Siemens has initiated a detailed investigation of the reported event.A root cause has not yet been identified.Siemens will submit a supplemental report with the results of the investigation when it has been completed.
Event or Problem Description
It was reported to siemens that during routine maintenance work on the collision drive, the siemens field service technician's phalange was jammed.The service technician was provided with first aid to treat the injury.Additional event information is pending.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 user error.The detailed investigation showed that the problem was not due to a malfunction of the system, but was caused by operator misconduct.The operator did not use the intended handles of the system but reached into the gap between the c-arm and the stand, which resulted in the index finger being squeezed.This was clearly contrary to the instructions for use and did not comply with the warning labels on the device.In principle, the system is designed to prevent possible crushing as far as possible.It has therefore been designed and also tested and approved in accordance with iec 60601-1.Despite all precautions, residual gaps remain between the moving and stationary parts of the system for mechanical reasons.Therefore, warning stickers have been attached to the system at these points and the remaining areas of risk have been described in detail or even illustrated in the instructions for use.The system has not malfunctioned and is working as specified.A possible accumulation of errors or even a systematic error that would lead to 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 SPIN
• Common Device Name: INTERVENTIONAL FLUOROSCOPIC X-RAY SYSTEM
• Manufacturer (Section D): SIEMENS HEALTHCARE GMBH - AT; siemensstrasse 1; forchheim, 91301 ; GM 91301
• Manufacturer (Section G): SIEMENS HEALTHCARE GMBH-AT; siemensstr. 1; forchheim, germany 91301 ; GM 91301
• Manufacturer Contact: meredith adams ; 40 liberty blvd.; 65-1a; malvern, PA 19355 ; 6104486461
• MDR Report Key: 13094470
• Report Number: 3004977335-2021-10357
• Device Sequence Number: 4192692
• Product Code: OWB
• UDI-Device Identifier: 04056869153506
• UDI-Public: 04056869153506
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K210054
• 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
• Type of Report: Initial,Followup
• Report Date (Section B): 12/28/2021

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?: Yes
• Operator of Device: Other
• Device Model Number: 10308194
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/21/2021
• Supplement Date Received by Manufacturer: 01/24/2022
• Initial Report FDA Received Date: 12/28/2021
• Supplement Report FDA Received Date: 01/24/2022
• 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