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

Model Number	11107444
Medical Device Problem Codes	Decoupling (1145); Electrical /Electronic Property Problem (1198)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/13/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
E1: the reporting facility contact phone number is (b)(6).H3, h6: initial corrective actions/preventive actions implemented by the manufacturer: no general problem has currently been detected for the installed base which requires an immediate action.Siemens healthineers has instructed the customer to not use the system until the complaint issue is resolved.Manufacturers preliminary analysis: the root cause of the issue has not been identified yet.Additional information was requested, and 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 made aware of a potential product problem associated with a mobilett elara max system.The user stated that every time the plug of the mains cable is removed from the socket, the housing of the plug slips, exposing wires and contacts.There was no injury associated with this issue.It is assumed that in a worst-case scenario, the user might receive a potentially fatal electrical shock if they touch the exposed wires while the plug is inserted in the socket.Historically, siemens healthineers has not been made aware of any fatal injury due to this type of issue.
Additional Manufacturer Narrative
D4: complete udi number was provided.H3, h6: siemens healthineers completed the detailed investigation of the reported issue.As previously reported, the mains plug is exposing the wires and contacts when unplugging.The provided pictures were analyzed, and it was found that the screw of the plug which attaches the internal part to the housing is missing or malfunctioning this allowed the plug housing to slide backwards when it is pulled out of the mains socket.The investigation showed that the root cause of the issue was most likely due to the operator unplugging the system by pulling the cord.This observation was also communicated by the service technician.This could have led to the mechanical stress on the assembly which caused the screw to loosen and fall off after continued use.Post market surveillance does not indicate a general problem with the assembly, including the plug screws.The correct handling for disconnecting the power cable is described in the system operator manual within the chapter "disconnecting the power cable".It is recommended to grip the plug to disconnect the mains cable.Thus, no additional force is applied to the cable.By performing the suggested daily safety checks the operator would be able to detect this kind of issue in case there is an obvious visual defect on the mains cable or the plug.The last maintenance was performed in (b)(6) 2023 by siemens healthineers local service.According to the maintenance protocol no mains cable issue was detected.This problem has already been resolved at customer site by the siemens healthineers service technician replacing the complete cable winch (11363871 - europe).The complaint is closed with this statement and without further measures.

• Brand Name: MOBILETT ELARA 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: 19545915
• Report Number: 3004977335-2024-00064
• Device Sequence Number: 6806585
• Product Code: IZL
• UDI-Device Identifier: 04056869154992
• UDI-Public: (01)04056869154992(21)12383
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: K182639
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 11/08/2024

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: 11107444
• 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: 06/13/2024
• Supplement Date Received by Manufacturer: 11/08/2024
• Initial Report FDA Received Date: 06/17/2024
• Supplement Report FDA Received Date: 11/08/2024
• 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