MAUDE Adverse Event Report: SIEMENS HEALTHINEERS AG MOBILETT MIRA MAX; SYSTEM, X-RAY, MOBILE

Model Number	10594738
Medical Device Problem Code	Electrical Power Problem (2925)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/03/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
H3, 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 reason for the damage to the power cable has not yet been identified.The investigation is ongoing.Siemens healthineers will submit a supplemental report if additional information is obtained upon completion of the investigation.
Event or Problem Description
Siemens healthineers was notified of an issue with the mobilett mira max system.It was communicated that the power cable was split, and wires were exposed near the mains plug.Sparks were created when attempting to charge the system.No injury occurred due to this event.It is assumed that in a worst-case scenario, the user might receive an electrical shock if they were to touch the exposed wires while the plug is inserted in the socket, resulting in death.As of the date of this report, siemens healthineers is unaware of serious injury of death having resulted due to this type of issue.
Additional Manufacturer Narrative
H3, h6: siemens healthineers completed the detailed investigation of the reported issue.Analysis of the provided pictures confirmed that the mains cable insulation sheath was damaged, and the internal cable were exposed.Such an issue is most likely caused by an incorrect daily operation when plugging out the mains cable.Either the system was moved before it was unplugged, or the cable was pulling out by directly holding the cable and not the plug.Another reason could be that the cable was pulled up and down during daily use.The correct handling for disconnecting the power cable is described in the system operator manual.Furthermore, with a daily safety check this kind of damage could be visually detected at an early stage.The last maintenance at this system was performed in december 2023 by siemens local service.No mains cable issues were detected at that time.The affected component has been replaced by the service technician.The product steering group monitors the concerned part cable winch, cpl.(usa) (10907348) and will decide about further measures, if needed.The complaint is closed with this statement and without further measures.

• Brand Name: MOBILETT MIRA MAX
• Common Device Name: SYSTEM, X-RAY, MOBILE
• Manufacturer (Section D): SIEMENS HEALTHINEERS AG; siemensstrasse 1; or rittigfeld 1; forchheim 91301 ; GM 91301
• Manufacturer (Section G): SIEMENS HEALTHINEERS AG; siemensstrasse 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: 19749721
• Report Number: 3004977335-2024-00078
• Device Sequence Number: 8987687
• Product Code: IZL
• UDI-Device Identifier: 04056869009131
• UDI-Public: (01)04056869009131
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• PMA/510(K) Number: K111912
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 11/23/2024

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: 10594738
• 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: 07/03/2024
• Supplement Date Received by Manufacturer: 11/22/2024
• Initial Report FDA Received Date: 07/16/2024
• Supplement Report FDA Received Date: 11/23/2024
• 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: A
• Patient Sequence Number: 1
• Patient Sex: Unknown