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

Model Number 10849000

Device Problems Positioning Problem (3009); Insufficient Information (3190)

Patient Problem Cardiovascular Insufficiency (4445)

Event Date 01/11/2024

Event Type  malfunction  

Event Description

Siemens became aware of an incident that occurred while operating the artis pheno system.A patient with a raptured aorta was admitted to the facility, where an immediate emergency procedure on the artis pheno was started simultaneously with the cardiopulmonary resuscitation (cpr) procedure.After several minutes of performing the cpr standing between the table and the detector, the user attempted to move the pheno c-arm away from the table to gain better access to the patient.This resulted in activation of the system collision sensors and no system movements were available.The user then moved the patient table away from the c-arm to continue with the cpr.However, it was reported that the patient passed away during the cpr.The relationship between the system failure and the patient death is unknown at this point in time.Siemens has requested additional information for this event.

Manufacturer Narrative

Siemens is conducting a thorough investigation of the reported event.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.Section h6: code 4756: c-arm.

Manufacturer Narrative

A patient with a raptured aorta was admitted to the facility.The patient was already intubated, and resuscitation began immediately upon arrival at the hospital.The c-arm of the artis pheno unit was located at the patient's table, when the user touched the detector resulting in activation of the collision sensor.Therefore, when the user tried to move the c-arm away from the patient table, but this was not possible.The user was aware of the emergency recovery function of the c-arm and preferred to turn the table for further resuscitation.During the resuscitation the patient passed away.According to the user, the death of the patient was not related to the system movement.Detailed analysis of the log files revealed that within an 8-minute time frame, the detector's collision sensors were activated and deactivated 244 times.Normally, slow system movements are possible with an active collision sensor in the override mode.However, in the described event, a toggling collision signal caused by multiple activations resulted in the override function to be reset with next activation of the collision sensor.As a result, virtually no system movement was available during this period as the override function would continuously be reset.Furthermore, the detector¿s collision sensor has a two-channel design and is monitored by a software.During the frequent activations, an scu (stand control unit) error occurred during monitoring, resulting in a ¿quick stop¿.As consequence the system switched to reduced stand/table speed.The message "reduced stand/table speed, sc" was displayed to the user.The defined recovery procedure for movement disturbances is a scu reset described in the operator manual, chapter 2.10.4/14.2.2.The log-file investigation showed that system movements were carried out after the continuous activations of the collision sensors and stopped when "quick stop" was active.System restart, which was performed at a later point in time on the same day, resolved the active ¿quick stop¿ issue.The occurrence rate of the aforementioned error pattern was checked.A possible error accumulation or even a systematic error, which leads to a corrective action of the installed base, could not be determined by the investigation.The incident described in the adverse event is not classified as a reportable event after a thorough investigation because the death that occurred is not related to the product defect, nor is the product defect expected to cause serious injury, death, or unexpectedly long hospitalization to the patient, even if the scu error occurs again.

• Brand Name: ARTIS PHENO
• 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: 18520375
• MDR Text Key: 333348659
• Report Number: 3004977335-2024-00004
• Device Sequence Number: 1
• Product Code: OWB
• UDI-Device Identifier: 04056869046877
• UDI-Public: 04056869046877
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: K201156
• 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,Followup
• Report Date: 03/18/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/16/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 10849000
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/18/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: A
• Patient Sequence Number: 1