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

Model Number 10094135

Device Problems Circuit Failure (1089); Electrical /Electronic Property Problem (1198); Fire (1245)

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

Event Date 03/04/2023

Event Type  malfunction  

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.

Event Description

Siemens became aware of an event that occurred while operating the artis zee floor unit.The central fire alarm was activated in the hospital, and the system turned off while the patient was on the table.The technicians noticed smoke coming out from the cath lab electricity cabinet room.They opened the room and found fire and smoke coming from one of the cabinets.The patient was transferred to a safe zone; the fire was put out with fire extinguishers.We have no indications of any adverse effects on the health status of any involved persons.Siemens has requested additional information in order to conduct an investigation of the reported event.

Manufacturer Narrative

The investigation on site showed that the hotspot of the heat development was located in the system cabinet in the region of the clamps from the secondary site of the transformer.Burned fuses, cables, and melted plastic cover over the clamps were caused by the heat from the hotspot region.Additionally, there were melted copper bubbles.According to the results of the investigation, the following scenario took place: 1.Short circuit between transformer and din rail feed-through clamp.2.Overheating, melting and fire of din rail feed through terminal block.3.Melting of wires between transformer and clamp (melted copper dropped onto transformer core).4.Possible arcing when current in melted transformer wires was interrupted.5.Plastic plate with labels located above terminal block catches fire.6.Fire of plastic plate melts circuit braker handles.7.Fire of plastic plate ignites neighboring wires.8.Molten plastic dropped on wires.The investigation also showed that external influences or influences from other materials or water, as the cause of the fault, can be excluded.Dust is also excluded as the system cabinet was in good condition and well maintained.The system in general was in a good condition despite 13 years of operation.However, it was not possible to determine the exact cause of the short circuit.According to the system experts, there are two very likely scenarios: 1.The isolation of the wires between the transformer and the clamps were damaged by unknown cause, which resulted in a short circuit directly after the secondary site of the transformer.2.The clamps heated up, which was caused by a loosen contact inside the clamps.Increased contact resistance of the heat generation caused temperature rise inside the clamp and, as a consequence, led to reduced isolation between the clamps resulting in a short circuit of the clamps.There are no similar cases known with such a failure pattern.All used components are ul-certified.In case electronic components become defective, they may emit smoke, heat and noise.This will stop after the source of energy (mains voltage) is cut off.The emitted gases are not poisonous.

• Brand Name: ARTIS ZEE FLOOR
• Type of Device: IMAGE-INTENSIFIED FLUOROSCOPIC X-RAY SYSTEM
• Manufacturer (Section D): SIEMENS HEALTHCARE GMBH-AT; siemenstrasse 1 or; rittigfeld 1; forchheim, 91301 ; GM 91301
• Manufacturer (Section G): SIEMENS HEALTHCARE GMBH-AT; siemenstrasse 1 or; rittigfeld 1; forchheim, 91301 ; GM 91301
• Manufacturer Contact: anastasia sokolova ; liberty blvd 40; mc 65-1a; malvern, PA 19355 ; 4843234897
• MDR Report Key: 16512146
• MDR Text Key: 310963920
• Report Number: 3004977335-2023-66232
• Device Sequence Number: 1
• Product Code: OWB
• Combination Product (y/n): N
• Reporter Country Code: EG
• PMA/PMN Number: K181407
• 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: 03/09/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/09/2023
• Is this an Adverse Event Report?: No
• 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: 03/30/2023
• 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