MAUDE Adverse Event Report: SIEMENS HEALTHCARE GMBH AXIOM ARTIS DTA; INTERVENTIONAL FLUOROSCOPIC X-RAY SYSTEM

Model Number 7008605

Device Problem Use of Device Problem (1670)

Patient Problem Death (1802)

Event Date 10/17/2019

Event Type  Death  

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 and subsequent adverse event occurred while operating the axiom artis dta system.The user reported that the system did not boot in operation mode until a complete power shut down was performed.It was reported that the patient passed away two days later.At this time, it is not known what type of procedure was being performed or if the procedure was continued and completed on an alternate system.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.The investigation showed that the system had a collimator error during start up.As intended for such an error; the system went into "bypass mode" and the error was indicated to the operator accordingly and the system was not operational after power on.According to the logfile the system recognized this error several days before the event and a warning was displayed to the operator accordingly.It is unknown why the system was used days later for an emergency procedure as it is alleged that the delay in treatment was critical to the patient's life.Due to the complexity of the system, the loss of x-ray imaging or other system functions during an examination or procedure cannot be completely excluded in case of the failure of a non-redundant system component.There is a maximum on risk mitigation applied in regards to the communicated failure; however, there remains a certain level of risk remaining from the system, its environment or other factors.This residual risk is foreseen to be covered by established appropriate emergency procedures of the operator, as described and considered in the instruction for use ( ifu).Specifically, there is a warning in the ifu concerning the need for establishing onsite emergency procedures to cover such cases.The affected collimator has been exchanged by the local service organization and the system works as specified.The manufacturer is not considering further actions resulting from this event as no systematic error has been recognized.

• Brand Name: AXIOM ARTIS DTA
• Type of Device: INTERVENTIONAL FLUOROSCOPIC X-RAY SYSTEM
• Manufacturer (Section D): SIEMENS HEALTHCARE GMBH; siemensstrasse 1; forccheim, germany 91301 ; GM 91301
• MDR Report Key: 9494573
• MDR Text Key: 171966665
• Report Number: 3004977335-2019-12260
• Device Sequence Number: 1
• Product Code: OWB
• Combination Product (y/n): N
• PMA/PMN Number: K052202
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Remedial Action: Inspection
• Type of Report: Initial,Followup
• Report Date: 12/17/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/19/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 7008605
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 03/26/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Death