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

Model Number	10594738
Medical Device Problem Code	Electrical Shorting (2926)
Health Effect - Clinical Code	Undesired Nerve Stimulation (1980)
Date of Event	07/06/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
H10 manufacturer narrative: h3; h6: initial corrective actions/preventive actions implemented by the manufacturer: the wall socket was replaced at the affected site.The cable winch of the system will also be replaced.No system malfunction has been determined at this time.No general problem has been detected for the installed base which requires an immediate action.Manufacturers preliminary analysis: it is currently assumed that a conducting material caused a short circuit at the pins of the plug when the system was plugged into the wall socket.No system malfunction was determined with the currently available information.The investigation is ongoing.A supplemental report will be submitted to the fda if additional information becomes available upon completion of the investigation.
Event or Problem Description
The system operator stated when she plugged the mobilett mira max system into the wall socket she heard a loud bang, and the socket was damaged.The socket and the socket cover were partly blackened.This was most likely caused by sparking.After this the operator had a tingling sensation in her hand which lasted a day.There was no patient involved in this incident.The provided information indicates that there was a short circuit caused by conducting material at the pins of the socket.This might have been caused by for example, a loose socket cover.The insulation of the system plug and of the cable were still intact.Currently no system malfunction has been identified.It is assumed that in worst-case scenario, the operator might receive an electrical shock under the described circumstances.The probability for a serious injury or death to occur under the described circumstances is assessed to be inconceivable.As of the date of this report, siemens healthcare has not become aware of any death due to such an issue.
Additional Manufacturer Narrative
B5: additional event information provided.H3, h6: siemens healthineers completed the detailed investigation of the complaint issue.It was initially stated that when the system was plugged into the wall socket, a loud bang was heard, and the socket was damaged.The user felt a tingling in her hand that lasted for one day.Images were provided showing the affected metal outlet and the defective us plug.Additional information stated that when the system was plugged in for charging, sparks, some smoke, and fire were noticed.The system was checked on site.No loose cables or cable isolation problems were detected.No defect boards or fuses were found.The investigation showed that a potential loose metal cover of the mains socket caused the described issue.It is concluded that a short circuit was created outside the system and only with the pins of the us plug and the metal cover of the socket during the plugging process.No system fault could be detected.During the plug-in process, the contact pins of the plug for phase and neutral, came into contact with the metal frame of the outlet cover.It is assumed that the two pins were already in contact with the mains power through the socket, resulting in a short circuit between the two pins through the metal cover.In this case, the metal cover acted as an electrical bridge between the phase and neutral pins.Additional information was received that the mains cable was twisted.In general, a twisted mains cable is due to heavy use of the cable.In this case, it was advised by siemens healthineers that the twisted cable winch be replaced to avoid further problems with internal wire breakage over time.
Event or Problem Description
Additional information.It was additionally stated by the customers that when the system was plugged in for charging, sparks, some smoke, and fire were noticed.
Additional Manufacturer Narrative
G4: this supplemental report was submitted to provide the reported system's 510(k) number which was omitted in error from the initial report.

• Brand Name: MOBILETT MIRA MAX
• Common Device Name: SYSTEM, X-RAY, MOBILE
• Manufacturer (Section D): SIEMENS HEALTHCARE GMBH; siemensstrasse 1 or; rittigfeld 1; forchheim 91301 ; GM 91301
• Manufacturer (Section G): SIEMENS HEALTHCARE GMBH; henkestrasse 127; rittigfeld 1; erlangen 91052 ; GM 91052
• Manufacturer Contact: rebecca tudor ; 40 liberty blvd., mc 65-1a; malvern, PA 19355 ; 4843234198
• MDR Report Key: 17351211
• Report Number: 3004977335-2023-00062
• Device Sequence Number: 14775663
• Product Code: IZL
• UDI-Device Identifier: 04056869009131
• UDI-Public: 04056869009131
• Combination Product (Y/N): N
• Initial Reporter State: PA
• 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,Followup
• Report Date (Section B): 08/02/2023

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: 07/06/2023
• Supplement Date Received by Manufacturer: 07/06/2023; 08/01/2023
• Initial Report FDA Received Date: 07/19/2023
• Supplement Report FDA Received Date: 07/21/2023; 08/02/2023
• 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