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

Model Number	10762471
Medical Device Problem Codes	Defibrillation/Stimulation Problem (1573); Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	Electric Shock (2554)
Date of Event	06/12/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
E1: the reporting facility contact name was not provided for reporting.The event was communicated by the siemens healthineers cse.The facility phone number is (b)(6).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.Manufacturers preliminary analysis: the root cause for the issue has not been identified yet.Additional information was requested for investigation.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
A siemens healthineers customer service engineer (cse) received a mild electric shock while replacing a charging relay on the luminos drf max system.There was no moderate or severe injury associated with this event.It is assumed that in a worst-case scenario, the cse might receive a potentially fatal electrical shock under the described circumstances.Historically, siemens healthineers had no knowledge of this type of issue resulting in a fatal electric shock.
Additional Manufacturer Narrative
H3, h6: siemens healthineers completed the detailed investigation of the reported issue.According to the complainant, an electrical shock occurred during the repair of the system when the inverter board d510 was replaced.It was also stated that the indicator leds (d510.V121/122) on the d510 board that show the current level of voltage of the intermediate circuit, were missing.The described issue occurred when the k2 relay in the generator was replaced.The relay loads the d510 board during startup and discharges when the system shuts down.The service technician further stated that after the event he measured the voltage of the discharge circuit of the inverter board to be 200v on l1 (d510.X51) against ground.The investigation of the provided d510 board by the supplier showed that the indicator leds are present on the board and function properly.The part showed corrosion in many places but would not have been delivered with such corrosion, according to the supplier.In general, a component with this grade of corrosion should not be installed in a system.It cannot be determined when the corrosion happened on the affected board and if the corrosion of the d510 led to a decreased speed of the discharge circuit.The technician later stated that he did not see the leds as they are difficult to see from certain angles.The luminosity of the leds, which show the charge status of the intermediate circuit, decreases with discharging of the intermediate circuit.According to the service technician, the generator main breaker f1 was switched off when starting the work on the generator.The service technician then waited a few minutes before measuring the voltage on the d510 board at one point.He stated that a voltage of 0.0043v was measured between d510.X53 l3 and earth.Measuring at one point is not sufficient.Measurements must be performed at other points also.He then began replacing the relay k2 and when touching a disconnected wire of relay k2, he received a mild electrical shock.As mentioned above, the service technician stated that he measured a voltage of 200v after the event.However, it is unclear how this voltage could be measured.When the system is switched off, it is not possible to measure any voltage against ground due to the internal design of the d510.The replacement of the generator components is described in the service documentation (polydoros service-relevant switches).The service document contains instructions to wait at least 2 minutes for the intermediate circuit voltage to drop to a level below 30v.It also contains information about the assemblies where voltage is still present even when the system is switched off and about the points that conduct voltage with the generator switched off and the system switched on.There is a "caution!" label in the generator.The following note is contained in the service documentation: ¿important: even after the generator has been switched off, there is still approximately 600 v dc present in the d510, d115, and d470 inverters.This is indicated by the v121 and v122 leds on the d510.The voltage dissipates in about two minutes to less than 30 v; the leds go off when it goes down to about 30 v.¿ (safety information and hazard keys - safety information).When the instructions above are considered and the leds are observed, there is no risk of electrical shock.Nevertheless, the issue is further tracked by the product steering group to improve the service documentation by explaining in detail how voltage measurements should be carried out.The complaint is closed with this statement and with reference to the upcoming measure.

• Brand Name: LUMINOS DRF 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; 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: 19613084
• Report Number: 3004977335-2024-00067
• Device Sequence Number: 6112565
• Product Code: OWB
• UDI-Device Identifier: 04056869009155
• UDI-Public: (01)04056869009155(21)7385
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• 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: Other,Foreign,Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• 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: Other
• Device Model Number: 10762471
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/12/2024
• Supplement Date Received by Manufacturer: 09/24/2024
• Initial Report FDA Received Date: 06/26/2024
• 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