MAUDE Adverse Event Report: SIEMENS HEALTHCARE GMBH AXIOM MULTIX, MT, ACSS,N; TABLE, RADIOGRAPHIC, NON-TILTING, POWERED

Model Number 8395399

Device Problem Fire (1245)

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

Event Date 10/24/2022

Event Type  malfunction  

Event Description

The user facility stated that the equipment caught fire.It was communicated that it started at the keyboard on the control console then spread to the monitor and surrounding components.The room was not being used at the time of the event.The issue was noticed by an odor coming from the room.It was further communicated that an alcohol bottle was standing nearby and that it caught fire.The user stated that he extinguished the fire by himself with a fire extinguisher.No one was injured during the event.The reported event occurred in portugal.

Manufacturer Narrative

Manufacturers preliminary analysis: the cause for the issue and the circumstances of the event are not understood yet.Basically, system parts are ul-certified, meaning that they are not flammable or will self-extinguish in case of thermal effects.Further information has been requested for investigation.Initial corrective actions/preventive actions implemented by the manufacturer: with the currently available information no general problem has been detected for the installed base which requires an immediate action.The investigation is ongoing.A supplemental report will be submitted if additional information is received by siemens.(b)(4).

Manufacturer Narrative

H10 additional manufacturer narrative: h3, h6: the reported issue was investigated in detail.According to provided information, it was stated that a fire started at the keyboard on the control console and then spread to the monitor and surrounding components.The equipment was turned on, but the system was not in use.The affected keyboard and monitor, including the power supply, have been received as complaint parts and have been investigated in detail by the materials testing department together with representatives of the suppliers.The keyboard and monitor show heavy burn marks.The keyboard has a power consumption of max.0.25w.This wattage is too low to start a fire.Therefore, it is assumed that the fire started at the monitor and spread to the keyboard, possibly by burning plastic that dripped from the monitor onto the keyboard.The monitor and keyboard were opened and inspected.No burn marks were found on the inside of either part.The main burn marks on the outside of the monitor were seen around the power supply socket.According to information from the local staff, there was a bottle of hand sanitizer/alcohol at the workspace.To determine if this disinfection agent was a possible root cause of the fire, a glowing wire was dipped in the same sanitizer used on the system.The tests showed that the wire cooled down immediately after dipping it into the sanitizer and did not cause any sign of flames.Therefore, it is very unlikely that the disinfectant caused the issue.A representative from the monitor's supplier stated that the issue may have been caused by a short circuit in the dc jack plug due to mechanical stress.Therefore, the material testing department performed a 3000-cycle bending test on an identical power supply cable.The images of the internal fracture of the cable did not show any specific signs of a short circuit.Therefore, it is considered unlikely that breakage due to frequent bending cycles of the cable would cause a short circuit.A short-circuit test of the same power supply, with the internal wires connected, showed temperatures up to 850°c.This is higher than the ignition temperature of the plastic housing of the monitor.After the thorough investigation it is assumed that the fire was most likely caused by a short circuit in the plug of the monitor power supply unit.However, the exact root cause could not be determined.The spare part consumption rates of monitor and keyboard show no general problem.Even though no general or systematic problem was identified, it is planned to replace all potentially affected monitor power supply units in the installed base as a precaution.

Manufacturer Narrative

H7: "recall" was checked in error in follow-up report #1 submitted to the fda on july 25, 2023.This field should have remained blank.H10: clarification/additional information of statement reported in follow-up report #1 "even though no general or systematic problem was identified, it is planned to replace all potentially affected monitor power supply units in the installed base as a precaution.": no remedial action has been initiated to replace all potentially affected monitor supply units as of the date of this report.A supplemental report will be submitted when all remedial actions to address this issue have been determined and the action has been formally initiated.

• Brand Name: AXIOM MULTIX, MT, ACSS,N
• Type of Device: TABLE, RADIOGRAPHIC, NON-TILTING, POWERED
• Manufacturer (Section D): SIEMENS HEALTHCARE GMBH; siemensstr. 1 or rittigfeld 1; forchheim, 91301 ; PO 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: 15715855
• MDR Text Key: 302866639
• Report Number: 3004977335-2022-50607
• Device Sequence Number: 1
• Product Code: IZZ
• Combination Product (y/n): N
• Reporter Country Code: PO
• PMA/PMN Number: K971452
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Health Professional,Company Representative
• Reporter Occupation: Other
• Remedial Action: Replace
• Type of Report: Initial,Followup,Followup
• Report Date: 07/31/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/02/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 8395399
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 07/28/2023
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1