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

Model Number	01818363
Medical Device Problem Code	Unintended Electrical Shock (4018)
Health Effect - Clinical Codes	Electric Shock (2554); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/22/2024
Type of Reportable Event	Malfunction
Event or Problem Description
Siemens became aware of a malfunction that occurred while operating the mobilett xp system.On june 26, 2024, siemens received information from the user that the operators were experiencing an electric shock like sensation when touching the system handle.No further information regarding this event was available, and it was initially classified as not reportable.It was assumed that the sensation was caused by electrostatic discharge.On july 2, 2024, additional information was received that the ground wire of the main cable was broken.It was then decided to report the issue, since a hazardous situation could not be excluded in case a second fault condition was present in the system.It was confirmed that there are no injuries related to this event.
Additional Manufacturer Narrative
Investigation of the event is on-going.A supplemental report will be submitted if additional information becomes available.
Additional Manufacturer Narrative
Siemens has completed an investigation of the event.It was stated that the component cable winder (india - 11433592) was defective and a ¿mild shock¿ issue occurred.The investigation showed that the earth protective cable inside the cable winder was broken.According to the information received from the service organization, the affected part was already exchanged.After replacement, all related measurements were passed including leakage current and protective earth measurement and no further similar issue was communicated during monitoring phase in the following month.The affected part was requested for a root cause analysis but was not available.Therefore, the investigation result is based on the received information and data.No other defect was found on the system that might have caused an electrical shock.Since the service technician described the incident as ¿mild shock,¿ an electrostatic discharge is most likely suspected.The last maintenance was performed in february 2024.As part of this maintenance the service technician also checked the cable winder.No issue was found in accordance with the maintenance protocol.Furthermore, the leakage current was measured without any deviations.It was not possible to determine what caused the damage of the cable winder.Shs internal post market surveillance does not indicate a general problem with the spare part.

• Brand Name: MOBILETT XP
• 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: meredith adams ; 40 liberty blvd.; malvern, PA 19355 ; 4843231631
• MDR Report Key: 19687992
• Report Number: 3004977335-2024-00074
• Device Sequence Number: 20865810
• Product Code: IZL
• UDI-Device Identifier: 04056869009087
• UDI-Public: (01)04056869009087
• Combination Product (Y/N): N
• Initial Reporter Country: IN
• PMA/510(K) Number: K033238
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Biomedical Engineer
• Type of Report: Initial,Followup
• Report Date (Section B): 08/27/2024

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: 01818363
• 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: 07/02/2024
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 07/08/2024
• Supplement Report FDA Received Date: 08/27/2024
• 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