MAUDE Adverse Event Report: SIEMENS HEALTHINEERS AG ARTIS Q ZEEGO; INTERVENTIONAL FLUOROSCOPIC X-RAY SYSTEM

Model Number 10848283

Device Problems Adverse Event Without Identified Device or Use Problem (2993); Insufficient Information (3190)

Patient Problem Insufficient Information (4580)

Event Date 01/09/2024

Event Type  malfunction  

Manufacturer Narrative

The concerned system was inspected by siemens local service.During the inspection it was found that the patient salvage device was open.It is unknown why the hatch of the patient salvage device was open as it must be opened intentionally.The cover must be removed to gain access to the hatch.The hatch only needs to be opened for rescue purposes.In the reported event the system behaved as expected with the hatch being open.The investigation is on-going.A supplemental report will be submitted when additional information becomes available.H6: 4755: patient salvage device hatch.

Event Description

Siemens became aware of an incident that occurred while operating the arts q zeego system during an emergency procedure.It was stated by the user that during the system start-up, all system movements were blocked and an error message ¿collision control deactivated¿ was displayed to the user.Due to this issue the emergency patient procedure that was planned on the concerned unit had to be performed with an alternate mobile c-arm system.Additional information stating that the patient passed away was provided to siemens.The relationship between the system behavior and the patient's death is unknown as of the date of this report.Siemens has requested additional information for this event.

Manufacturer Narrative

The investigation of the reported event was completed by siemens.An 86-year-old female patient diagnosed with a covered rupture of the abdominal aorta was scheduled to undergo an endovascular aortic repair (evar) procedure on the artis zeego system.At the start of the procedure, system movements were blocked.The evar procedure was continued on the artis zeego unit using a mobile c-arm, which is an adequate system for performing the procedure for the clinical picture described.The length of the procedure delay was described by the user as short; no exact length of the delay was provided.However, during the follow-up the patient passed away due to multi-organ failure.The investigation of the log file revealed that the patient salvage device flap* was opened at 10:14 a.M.Before the system shut down.After the system was switched on again in the early afternoon for an emergency procedure, the flap was still open, and no system movements were available.The user received the message ¿collision control deactivated¿, however, the user was not aware that the flap was still open.It was determined that the emergency rescue function had not been used.There is no information available to why the flap had been opened.In general, the flap cannot open by itself.The flap is magnetically fixed and must be opened against gravity force.The operator manual states that the patient salvage function is intended as a recovery procedure to rescue the patient in case of severe functional disturbances, e.G.Power failure only and its activation may lead to limited / lost functionality, resp.Restrict further clinical usage.The operator is explicitly instructed to restore the normal state after using the patient salvage functionality.Besides, an open flap can easily be identified during a system check as recommended in the operator manual before an examination.An open flap prevents the outer flap door at the cover to be closed completely.The cover flap remains visibly open at least with an angle of ~15°.Closing the flap, restores all system movements.Based on the limited clinical information, there is no indication, that the unavailability of the artis zeego impacted the patient¿s further clinical treatment.However, a conclusive assessment cannot be made, though, a causal relationship is very unlikely.The investigation did not reveal any system deficiency.A more comprehensible indication of whether the stand movements are blocked due to an active salvage function, i.E., the flap is open, will be considered for future improvements.At the rear of the stand base the cover can be opened to access a small flap.Underneath this flap a handheld device is located.This handheld device can be used in an emergency (e.G.Power failure) to release the brakes for stand swivel and c-arm rotation to move these axles manually to gain better access to the patient.Technically, an open patient salvage flap blocks any stand movements.This is an essential measure to ensure that the system is not moving when the operator pushes the patient salvage button at the handheld (stored in the box accessible after opening the flap) which leads to opening the brakes at two axes, so that the system can be moved by manually by hand to allow the patient to be rescued.Table movements with reduced speed remain available.The box with the handheld and the flap is found below a flap door at the outer cover.Opening this outer flap door alone does not impact / restrict system movements.While the inner flap is open, the message "collision control deactivated" is displayed to the user.

• Brand Name: ARTIS Q ZEEGO
• Type of Device: 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: anastasia sokolova ; 40 liberty blvd.; malvern, PA 19355 ; 4843234197
• MDR Report Key: 18731301
• MDR Text Key: 336652684
• Report Number: 3004977335-2024-00021
• Device Sequence Number: 1
• Product Code: OWB
• Combination Product (y/n): N
• Reporter Country Code: SW
• PMA/PMN Number: K181407
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Health Professional
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 02/19/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/19/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 10848283
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/07/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: A
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 86 YR
• Patient Sex: Female