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

Model Number 10848281

Device Problem Mechanical Problem (1384)

Patient Problem Cardiac Arrest (1762)

Event Date 03/18/2022

Event Type  Death  

Event Description

It was reported to siemens that a malfunction occurred while operating the artis q ceiling system.During an interventional procedure, the user reported that the c-arm was moving very slowly.Additional information was provided that the patient required cpr.According to the information given, the cpr was performed in such a way that caused damage to the c-arm.Cpr was unsuccessful and the patient passed away.Siemens has requested additional information in order to conduct an investigation of the reported event.

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.

Manufacturer Narrative

Siemens has completed an investigation of the reported event.The root cause was determined to be a hardware error.The investigation was performed considering complaint description, cs reports, system history, and system log files.During an interventional procedure, cardiopulmonary resuscitation (cpr) had to be performed on the patient.For unrestricted access to the patient, the customer moved the c-arm out of the patient area.In doing so, the c-arm collided with the table, allowing the system to move only in "override mode" at reduced speed.Unfortunately, resuscitation was unsuccessful and the patient died.The customer confirmed that the defective system did not interfere with the performance of cpr.The investigation also found no causal relationship between the system failure and the patient's death.Failure investigation revealed that the collision had broken a wire of the proximity switch of the c-arm.Up to this point, the system was still functioning as intended.As a result, the proximity switch became permanently active and movement of the system was only possible in override mode.The operator manual contains adequate instructions for the safe operation of the system in this failure scenario, which have been applied accordingly by the customer.The exchange of the proximity switch resolved the problem.The occurrence rate of the 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 defect occurs again.

• Brand Name: ARTIS Q CEILING
• Type of Device: INTERVENTIONAL FLUOROSCOPIC X-RAY SYSTEM
• Manufacturer (Section D): SIEMENS HEALTHCARE GMBH-AT; siemensstr. 1; forchheim, germany 91301 ; GM 91301
• Manufacturer (Section G): SIEMENS HEALTHCARE GMBH-AT; siemensstr. 1; forchheim, germany 91301 ; GM 91301
• Manufacturer Contact: meredith adams ; 40 liberty blvd.; malvern, PA 19355 ; 4843231631
• MDR Report Key: 13860776
• MDR Text Key: 287678390
• Report Number: 3004977335-2022-20905
• Device Sequence Number: 1
• Product Code: OWB
• UDI-Device Identifier: 04056869009988
• UDI-Public: 04056869009988
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K181407
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Company Representative
• Reporter Occupation: Other
• Remedial Action: Repair
• Type of Report: Initial,Followup
• Report Date: 03/22/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/23/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 10848281
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 04/11/2022
• 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