MAUDE Adverse Event Report: SIEMENS HEALTHINEERS AG UROSKOP OMNIA MAX; INTERVENTIONAL FLUOROSCOPIC X-RAY SYSTEM

Model Number	10762473
Medical Device Problem Code	Device Fell (4014)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/15/2024
Type of Reportable Event	Malfunction
Event or Problem Description
Siemens healthineers became aware of an issue with the uroskop omnia max system.It was communicated to siemens healthineers that the 19-inch monitor protection cover fell off near the patient but did not hit the patient.No one was injured during the event.It is assumed that in a worst-case scenario, serious injury could result from falling parts if the event were to reoccur.
Additional Manufacturer Narrative
H6: initial corrective actions/preventive actions implemented by the manufacturer: no general problem has been detected for the installed base which requires an immediate action.Manufacturer's preliminary results and conclusion: the root cause of the cover falling off has not yet been determined.The investigation is ongoing.A supplemental report will be submitted to the fda upon completion of the investigation.
Additional Manufacturer Narrative
H3: the complaint component was not returned for investigation by siemens healthineers.The complaint component was inspected by the siemens service technician.Siemens healthineers completed the detailed investigation of the reported issue.The protection cover of the 19¿ monitor has magnetic strips on the backside and metal strips surround the monitor frame to hold the protection cover.According to the information of the service organization, the metal strips were still in place on the monitor frame.Therefore, the issue was not caused by missing metal strips.The magnetic strips were found free of dust and/or liquids.The protection cover was requested for investigation.However, it was already scrapped locally by the service technician.Therefore, this issue cannot be investigated in further detail.In general, extreme heat, a strong magnetic field or impacts on the magnet can lead to a weakening of the magnet.According to the information of the service organization, the described issue was solved by a service technician by replacing the affected part protective cover barco mdrc-1119 (material number: 10594708).Shs internal post market surveillance does not indicate a general problem with the part.Since no general problem or additional risk was identified, the complaint is closed with this statement and without further measures.

• Brand Name: UROSKOP OMNIA MAX
• Common Device Name: INTERVENTIONAL FLUOROSCOPIC X-RAY SYSTEM
• Manufacturer (Section D): SIEMENS HEALTHINEERS AG; siemensstrasse 1; or rittigfeld 1; forchheim 91301 ; GM 91301
• Manufacturer (Section G): SIEMENS HEALTHINEERS AG; siemensstr. 1 or rittigfeld 1; or rittigfeld 1; forchheim 91301 ; GM 91301
• Manufacturer Contact: rebecca tudor ; 40 liberty blvd., mc 65-1a; malvern, PA 19355 ; 4843234198
• MDR Report Key: 19937102
• Report Number: 3004977335-2024-00100
• Device Sequence Number: 11981217
• Product Code: OWB
• UDI-Device Identifier: 04056869008981
• UDI-Public: (01)04056869008981
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• PMA/510(K) Number: K173639
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 09/24/2024

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: 10762473
• 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: 07/15/2024
• Supplement Date Received by Manufacturer: 09/24/2024
• Initial Report FDA Received Date: 08/08/2024
• Supplement Report FDA Received Date: 09/24/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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: A
• Patient Sequence Number: 1
• Patient Sex: Unknown