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

Model Number 10502502

Device Problem No Apparent Adverse Event (3189)

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

Event Date 05/01/2022

Event Type  malfunction  

Manufacturer Narrative

Siemens conducted a retrospective review and has revaluated this complaint.Siemens has now deemed that that this complaint meets the requirement for reporting under 21 cfr 803.This mdr is submitted on july 25, 2023 due to the manufacturer receiving clarification that mdrs are required for similar devices marketed by the manufacturer, even if it is not 510(k) cleared or imported to the united states.The device listed in section d of this report is not an fda 510(k) cleared medical device, but is similar to the artis zee device which is cleared in the united states under k181407.Siemens has completed an investigation of the event.The root cause was determined to be a hardware error.According to the logfiles, early in the morning after the first system startup, the real time controller (rtc) displayed warnings and errors due to lack of communication.The user performed three reboots until about 08:10 am, which did not fix the problem.Because the system was not operational, the patient was transferred to another hospital for treatment.It was reported that the patient passed away during transport.An onsite service intervention showed a problem with the rtc.The detailed rtc investigation revealed a defective basis hardware, which was a result of a water damage.Where or how the water entered the hardware could not be determined by the investigation.The instruction for use (ifu) gives adequate advice not to let cleaning liquids seep into the openings of the system.After the exchange of the rtc, the system worked as specified.Due to the complexity of the system, the loss of x-ray imaging or other system functions during, or in this case before a procedure, cannot be completely excluded in case of the failure of a non-redundant system component.The ifu advises the user to consider the need to establish emergency procedures for such cases.The occurrence rate of the aforementioned error pattern was checked.A possible error accumulation or even a systematic error, which would lead to a corrective action of the installed base, could not be determined by the investigation.

Event Description

It was reported to siemens that an adverse event occurred while operating the artis zee iii ceiling system.Before an interventional procedure, the user reported that the rtc start up failed.The patient was transferred to another hospital for treatment and it was reported that the patient passed while being transported to another hospital.The patient's condition prior to transport is not known.

Manufacturer Narrative

Siemens conducted a retrospective review and has revaluated this complaint.Siemens has now deemed that that this complaint meets the requirement for reporting under 21 cfr 803.This mdr is submitted on july 25, 2023 due to the manufacturer receiving clarification that mdrs are required for similar devices marketed by the manufacturer, even if it is not 510(k) cleared or imported to the united states.The device listed in section d of this report is not an fda 510(k) cleared medical device, but is similar to the artis zee device which is cleared in the united states under k181407.Correction: h1: type of reportable event: malfunction information available for investigation does not show that the patient death was a result of a device malfunction.

• Brand Name: ARTIS ZEE III CEILING
• Type of Device: INTERVENTIONAL FLUOROSCOPIC X-RAY SYSTEM
• Manufacturer (Section D): SIEMENS HEALTHCARE GMBH-AT; siemensstr. 1- or-; rittigfeld 1; forchheim, germany 91301 ; GM 91301
• Manufacturer (Section G): SIEMENS HEALTHCARE GMBH-AT; siemensstr. 1- or-; rittigfeld 1; forchheim, germany 91301 ; GM 91301
• Manufacturer Contact: meredith adams ; 40 liberty blvd.; malvern, PA 19355 ; 4843231631
• MDR Report Key: 17389303
• MDR Text Key: 319679000
• Report Number: 3004977335-2023-26383
• Device Sequence Number: 1
• Product Code: OWB
• Combination Product (y/n): N
• Reporter Country Code: CH
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Health Professional
• Reporter Occupation: Other
• Remedial Action: Repair
• Type of Report: Initial,Followup
• Report Date: 07/25/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/25/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 10502502
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 05/19/2022
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Death