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

Model Number 10094135

Device Problem Radiation Output Failure (4027)

Patient Problems Pain (1994); Discomfort (2330)

Event Date 10/06/2022

Event Type  malfunction  

Event Description

Siemens became aware of a malfunction that occurred on the artis zee floor unit.A patient with acute inferior myocardial infarction was admitted to the hospital.During an emergency procedure, the unit was not able to release radiation and displayed an error ¿tube too hot¿.This caused a delay of the procedure as well as increased the amount of heparin used during the operation.Following completion of the procedure, the patient complained of long-term back pain and discomfort.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 event.As this event is under investigation, a root cause has not yet been determined.A supplement report will be filed if additional information becomes available.

Manufacturer Narrative

H3, h6: the investigation was performed based on expert discussions considering complaint description, customer service reports, and system history.According to the available information, during an emergency case x-ray was blocked and the error message "no xray, tube too hot" was displayed.The procedure was then continued and finished using an alternative system.Initially, the possible health consequences of the patient were indicated as long-term pain and discomfort in the back.However, the patient recovered and was discharged from the hospital.No long-term health consequences were communicated.Upon investigation the involved customer service employee (cse) exchanged the cooling unit.After that the system recovered.An extensive investigation could not be performed because the cooling unit was not returned for a detail investigation.The cause of the complaint could not be determined retrospectively.Subsequently, a multi-stage detection and warning mechanism was activated, so that the system displayed the message "tube hot, have a break" to the user.The user continued x-ray and, as a result a hardware switch was activated, disabling the x-ray and displaying "no x-ray, tube too hot".After the exchange of the cooling unit there were no further issues as described in the complaint description and the system works as intended.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.

• Brand Name: ARTIS ZEE FLOOR
• Type of Device: INTERVENTIONAL FLUOROSCOPIC X-RAY SYSTEM
• Manufacturer (Section D): SIEMENS HEALTHCARE GMBH; siemensstrasse 1 or; rittigfeld 1; forchheim 91301 ; GM 91301
• Manufacturer (Section G): SIEMENS HEALTHCARE GMBH; siemensstrasse 1; or rittigfeld 1; forchheim 91301 ; GM 91301
• Manufacturer Contact: rebecca tudor ; 40 liberty blvd., mc 65-1a; malvern, PA 19355 ; 4843234198
• MDR Report Key: 17227551
• MDR Text Key: 318176009
• Report Number: 3004977335-2023-00053
• Device Sequence Number: 1
• Product Code: OWB
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: K181407
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 10/04/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/29/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 10094135
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/29/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Type of Device Usage: A
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 75 YR
• Patient Sex: Female