MAUDE Adverse Event Report: GETINGE IC PRODUCTION POLAND SP. Z O.O TORNADO; WASHER OF BODY WASTE RECEPTACLES

Model Number FD1810

Device Problem Fire (1245)

Patient Problems No Patient Involvement (2645); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 09/30/2020

Event Type  Injury  

Manufacturer Narrative

Please note that previous medwatch reports for this product may have been submitted under the following registration number: 3012068831.Currently, these products are to be handled by arjohuntleigh ab¿s complaint handling establishment and any medwatch reports will be submitted under registration #3007420694.According to the received information, the device was not functioning after the incident.The steam generator was leaking due to faulty gasket.Electrical connections were found oxidized due to leaking steam.The investigation is ongoing and further information will be provided in the next report.Device at the 3rd party site.

Event Description

Arjo was notified about an event with involvement of tornado washer.It was initially reported that the device created a fire, it was generating a lot of smoke and burned smell.The department at the customer's facility required cleaning.

Manufacturer Narrative

The device is under evaluation, arjo is awaiting additional details from the investigating company.The investigation is ongoing and further information will be provided in the next report.

Manufacturer Narrative

The device is to be evaluated further in order to determine a cause of the malfunction.The investigation is ongoing and further information will be provided in the next report.

Manufacturer Narrative

Arjo was notified about an event with involvement of tornado washer.It was reported that the device created a fire, it was generating a lot of smoke and burning smell.The department at the customer's facility required cleaning.No patient involvement and consequences were reported.According to the received information, the device was not functioning after the incident.It was initially stated that the steam generator was leaking due to faulty gasket in middle part of the assembly.Electrical connections were found oxidized due to leaking steam, which led to the short circuit.The device was evaluated further for purpose of the cause identification.According to the results, the damage was limited to the water heater in the bottom compartment of the unit.The thermal insulation displayed charring on the rear of the water heater.The front plastic cap of the water heater was slightly melted on top.The steam generator was removed and further observations were made.The metal enclosure of the steam generator was discoloured and oxidized by the heat.One of the generator¿s electrical supply leads was severed and was melted at its end.The cavity in the water tank, where this supply lead was connected to the heating element, was punctured, which most likely caused the steam generator to leak.The electrical contacts of the thermostat switch displayed some pitting.Based on the collected information the leakage from puncture in steam generator contributed to a corrosion and damage of the electrical contacts.This led to the device¿s abnormal overheating and alleged fire occurrence.Following collected information, the incident was primarily a result of the product¿s component failure.Taking into account the device condition after the event and a period of its usage it was not possible to determine the exact root cause of the steam generator leaks.The seal of the steam generator enclosure could have been damaged due to overheating which resulted in additional water leakage.The reported event could have been prevented by following the maintenance routine.Therefore, the device ignition was partially a consequence of insufficient maintenance activities.According to the performed evaluation and condition of the components, wear and corrosion due to water exposure were progressing over unknown period of time leading to failure of the electrical components, short circuit, overheating and reported incident¿s occurrence.According to the tornado user manual, a periodic maintenance and system testing must be performed to ensure safety and the machine's proper operation.The amount of maintenance required depends largely on the quality of the incoming water and how often the machine is used.The maintenance interval needs to be determined in each individual case.Manufacturer recommendation is to perform maintenance according to the intervals included in the manual.The maintenance may only be performed by the authorized and trained service personnel.According to the schedule condition and function of the steam generator and related components should be performed at least every year or after 10,000 cycles.It should comprise of: - check the connections to the steam generator for leakage and make sure the surrounding insulation is intact and no hot surfaces are exposed.- check that the steam generator is working properly.During the preventive maintenance the qualified technician should also check the cabling and electrical connection points to confirm their satisfying condition and operation.The involved device was not covered by the arjo service agreement at the time of event and was maintained mainly by the customer facility.The device was serviced by arjo occasionally, upon the customer request and according to the order.As per service history of the device last service was performed by arjo took place in march 2020 (almost 8 months before the incident).Its purpose was to replace the temperature sensor after the earlier initial assessment of the device, which revealed malfunction of this component.The device was repaired, function tested and put back to use.This malfunction was not connected with the later failure (leak) of the steam generator.Parts used for assembly of tornado flusher are made of ul-certified materials and are fire retardant.The materials of the enclosure have a flammability classification of v-1 or better.The steam generators have an overheat protection which activates if the temperature in the steam generator goes too high.If the element overheats, the power is cut to the element, and error code f7 appears on the devices¿ display because the disinfection temperature has not been achieved.In the investigated case the overheating protection could have been damaged due to leak, which impaired its functioning.In summary, according to the gathered information the involved tornado flusher was most probably used, when the event occurred.Based on the performed evaluation of the device, its steam generator was damaged due to overheating therefore the device was not according to the manufacturer¿s specification.As per the collected information, no injury or other health consequences were reported to be a result of this event.This complaint was decided to be reported to the regulatory authorities in abundance of caution due to initial indication of a fire occurrence.

Manufacturer Narrative

The device is still under evaluation; waiting for additional details from the investigation.Further information will be provided in the next report.

• Brand Name: TORNADO
• Type of Device: WASHER OF BODY WASTE RECEPTACLES
• Manufacturer (Section D): GETINGE IC PRODUCTION POLAND SP. Z O.O; ul. szkolna 30, plewiska; plewiska PL-62 064; PL PL-62064
• MDR Report Key: 10770098
• MDR Text Key: 214096207
• Report Number: 3007420694-2020-00168
• Device Sequence Number: 1
• Product Code: FLH
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: user facility
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date: 02/26/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: FD1810
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: 10/08/2020
• Initial Date FDA Received: 11/02/2020
• Supplement Dates Manufacturer Received: 10/08/2020; 10/08/2020; 10/08/2020; 10/08/2020
• Supplement Dates FDA Received: 12/01/2020; 12/30/2020; 01/28/2021; 02/26/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other