MAUDE Adverse Event Report: SIEMENS HEALTHCARE GMBH- AT ARTIS ZEE FLOOR; INTERVENTIONAL FLUOROSCOPIC X-RAY SYSTEM

Model Number 10094135

Device Problem No Apparent Adverse Event (3189)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 06/03/2021

Event Type  malfunction  

Manufacturer Narrative

Siemens is conducting a thorough investigation of the reported events.As this event is under investigation, a root cause has not yet been determined.A supplement report will be filed upon completion of the investigation.

Event Description

It was reported to siemens that a malfunction occurred while operating the artis zee floor system.During a regulatory control, the recorded dose rate was higher than expected.We are unaware of any impact to the state of health of any patient or user involved.Siemens has requested additional information in order to conduct an investigation of the reported event.

Manufacturer Narrative

Siemens has completed an investigation of the reported event.The root cause was determined to be a hardware error in combination with a user error.The customer reported that during a regulatory control, the recorded dose rate was higher than expected.Based on customer information, the technical investigation is divided into three claims: 1) collimator issue - cu pre-filter failure occurred.2) error messages - error messages will be displayed every time when radiation is requested, and the pre-filter failed.3) maximum dose rate - during common control, when controlling the maximum dose rate at the patient's entry (low dose mode) the value seems to be out-of-tolerance.The investigation was performed considering complaint description, customer service reports, system history, simulation in the factory, and system log files.The detector, which includes the pre-filter, was not returned for evaluation; therefore, the root cause of the hardware problem could not be determined retrospectively.Claim 1) the complaint text states a potential dose increase up to 400mgy/min, however, this is not possible because the artis system exposure management is based on the detector dose.Considering that the detector will receive a higher dose with lower filtration, the exposure regulation will reduce the exposure parameters and accordingly, the dose applied to the patient, which is limiting the potential of applying additional exposure to the patient.The examples of manual recalculation, based on the event logs, show that the requested and current detector dose given are equivalent.This means that the regulation and control circuit were always working, even if the cu pre-filter failed.Based on the available data there is no significant increase of total skin dose for the patients.Additionally, the applied dose is displayed at any time to the operator.Claim 2) log file analysis showed the customer decided to continue working with the system after an error message with the cu pre-filter first occurred on (b)(6) 2021.When radiation was requested and the pre-filter failed; the message "possibly wrong dose, cu pre-filter, sc" was displayed on the monitor.This issue was ongoing for approximately 3 months.The error message was displayed every time radiation was requested to inform the customer of the error until the cu pre-filter was exchanged by a siemens customer service engineer on 2021-07-29.Based on the available data, a malfunction did not occur; in that the system identified a component error and indicated this to the user in the form of an error message.The system was operating as intended.The error handling of such an error (marked with sc) is part of the operator manual: chapter: troubleshooting, sub-chapter: error handling: in case of a fault or during startup/shutdown, system status messages are displayed that indicate restrictions.Operating restrictions that only the service center can remedy are marked with ".Sc.".Chapter: system messages / troubleshooting, sub-chapter:.With fault messages marked ".Sc": ".Sc" a serious fault has occurred.- note down - the text of the message - the time of the fault (date/time) - the function that was executed when the fault occurred this information is useful for our service personnel.- if necessary, perform a restart.- if the message is displayed again: contact siemens service.Claim 3) according to the available data, no regulatory values were exceeded within the time given.However, it is theoretically possible that under worst-case assumptions (e.G., pre-filter defect, dose indication not considered, worst-case angulation, thick phantom (increased water value) or additional material in the x-ray beam) and ignoring the normative measurement requirements of iec 60601, the regulatory values could be exceeded.If the tests were carried out in accordance with standard practices (iec 60601), the regulatory values indicated by the customer are not reproducible.After detailed investigation, the incident is not classified as a reportable event as neither serious injury, death, nor an unexpected, prolonged hospitalization of the patient or any other person occurred or could be expected.

• Brand Name: ARTIS ZEE FLOOR
• Type of Device: INTERVENTIONAL FLUOROSCOPIC X-RAY SYSTEM
• Manufacturer (Section D): SIEMENS HEALTHCARE GMBH- AT; siemensstrasse 1; forchheim, germany 91301 ; GM 91301
• MDR Report Key: 12299773
• MDR Text Key: 265768305
• Report Number: 3004977335-2021-91803
• Device Sequence Number: 1
• Product Code: OWB
• UDI-Device Identifier: 04056869010045
• UDI-Public: 04056869010045
• Combination Product (y/n): N
• PMA/PMN Number: K181407
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Remedial Action: Repair
• Type of Report: Initial,Followup
• Report Date: 08/10/2021

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
• Device Operator: Health Professional
• Device Model Number: 10094135
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: 08/03/2021
• Initial Date FDA Received: 08/10/2021
• Supplement Dates Manufacturer Received: 09/30/2021
• Supplement Dates FDA Received: 09/30/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1