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

Model Number 10094137

Device Problem Mechanical Problem (1384)

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

Event Date 01/07/2021

Event Type  malfunction  

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 occurred while operating the artis zee ceiling system.During an interventional procedure, the user reported that the image was rotating sideways.The procedure could not be completed due to the malfunction.We are unaware of any impact to the state of health of the patient involved.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 configuration error.The detailed investigation revealed that the error was caused by an erroneous configuration file.Although it is not possible to prove retrospectively how this file was used, our system specialists assume that the error may have occurred during the last service.This hypothesis is supported by the fact that the system was serviced shortly beforehand, during which the real-time computer (rtc) was replaced, and the error described subsequently occurred during the first use of the system.Consequently, the system issued an error message stating that the system needed to be adjusted, which required service intervention.After an rtc download and appropriate calibration of the system by our local service organization, the system ran again as specified.A possible general error that would require corrective action of the installed base could not be determined by the investigation.After detailed investigation, the incident is not classified as a reportable event as neither serious injury, death nor an unexpected, prolonged hospitalization of the patient or any other person occurred or could be expected.

• Brand Name: ARTIS ZEE CEILING
• Type of Device: INTERVENTIONAL FLUOROSCOPIC X-RAY SYSTEM
• Manufacturer (Section D): SIEMENS HEALTHCARE GMBH- AT; siemensstrasse 1; forchheim, germany 91301 ; GM 91301
• MDR Report Key: 11192689
• MDR Text Key: 228172690
• Report Number: 3004977335-2021-62952
• Device Sequence Number: 1
• Product Code: OWB
• UDI-Device Identifier: 04056869010052
• UDI-Public: 04056869010052
• Combination Product (y/n): N
• PMA/PMN Number: K181407
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Remedial Action: Repair
• Type of Report: Initial,Followup
• Report Date: 01/19/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/19/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 10094137
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 04/12/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1