MAUDE Adverse Event Report: GETINGE DISINFECTION AB TYPHOON; WASHER OF BODY WASTE RECEPTACLES

Model Number SP6000

Device Problem Fire (1245)

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

Event Date 02/22/2022

Event Type  malfunction  

Manufacturer Narrative

Please note that previous medwatch reports for this product may have been submitted under the following registration numbers: (b)(4).Currently, these products are to be handled by arjohuntleigh ab¿s complaint handling establishment and any medwatch reports will be submitted under registration #(b)(4).The device was evaluated by an arjo representative on site.This inspection revealed that the steam generator inside the flusher ignited and melted the bottom of the washer chamber.Analysis of collected information is ongoing to provide the final conclusions.

Event Description

Arjo received a customer complaint where it was reported that a typhoon flusher started smoking while cleaning a bedpan.Smoke caused the evacuation of the er and fire department was called in.According to the additional information gathered the facility staff thought there was just steam but they realized there was a smoke and a visible flame.A fire extinguisher was used to put out the flames but the material reignited two for a total of three separate flame instances.The flusher was disconnected from power by an electrician and the incident was contained.No one was injured and no other facility damage was incurred.

Manufacturer Narrative

The returned steam generator was inspected by an arjo product engineer to find possible causes of the flame.The evaluation revealed that the generator had no signs of limescale or other contamination found.The generator was working under good conditions.Ignition did not occur as a result of overheated cables or an electrical short.The entire generator was burned out.It was indicated that one of the three heaters had a damaged mounting point and that the steam generator became unsealed in this place.In summary, the likely cause of the generator burning was a leak in the generator where the heater is connected to the generator wall.As a result of this failure, the entire volume of water spilled out of the generator.The empty generator rapidly heated up to a very high temperature, causing the generator to overheat leading to ignition.Analysis of collected information is ongoing to provide the final conclusions.

Manufacturer Narrative

The defective part will be returned for further examination.Analysis of collected information is ongoing to provide the final conclusions.

Manufacturer Narrative

A claim to the supplier has been raised and testing results performed by arjo product engineer has been shared with the supplier.The addition information will be provided upon investigation conclusion.

Manufacturer Narrative

Investigation is still ongoing.A claim to the supplier has been raised and testing results performed by arjo product engineer has been shared with the supplier.At this time we are waiting for feedback from the supplier.The additional information will be provided upon investigation conclusions.

Manufacturer Narrative

Arjo was notified about an incident with involvement of typhoon flusher.It was stated that the device caught fire.The customer facility personnel used fire extinguisher to stop it, but the material reignited.The flusher was disconnected from power by an electrician and the incident was contained.No one was injured and no other facility damage was incurred.Following the information collected, the incident was a result of the product¿s component failure - a steam generator.The part was returned to the manufacturer and evaluated further for purpose of the cause identification.According to the results, the entire steam generator was burned out.However, there was no signs of limescale or other contamination and this part had been working under good conditions.It was indicated that one of the three heaters had a damaged mounting point and that the steam generator became unsealed in this place.The likely cause of the generator burning was a leak in the generator where the heater is connected to the generator wall.As a result of this failure, the entire volume of water spilled out of the generator.This led to abnormal overheating of this part and alleged fire occurrence.The ifu for typhoon flusher includes safety precaution for the device user: "in an emergency: switch off the main switch".To sum up, according to the gathered information the involved typhoon flusher was used, when the event occurred.Based on the performed evaluation of the device, the 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 indication of a fire occurrence.

Manufacturer Narrative

Further investigation was performed for the involved typhoon flusher and some conclusions were changed.Therefore, it was decided to update final conclusions from the previous investigation and inform competent authorities about the new findings.Arjo was notified about an incident with a typhoon flusher.It was indicated that the typhoon flusher ignited during a cleaning process of a bedpan.When an electrician disconnected the flusher from the power supply, the fire was contained.No one was injured and no other facility damage was incurred.The steam generator was returned to the manufacturer for further evaluation in order to determine the root cause.The qualitative analysis performed revealed that the entire steam generator was burned.It was indicated that one of the three heaters, which is placed inside the steam generator, had a damaged mounting point.This damaged mounting point caused the steam generator to become unsealed.The likely cause of the steam generator burning was a water leak in the steam generator where the heater is connected to the steam generator¿s wall.As a result of this failure, the entire volume of water spilled out of the steam generator.This led to the part overheating and subsequent fire.The burnt steam generator was a previous design.According to the label placed on the returned steam generator involved in the incident, it was found that this steam generator was a previous design steam generator - manufactured prior to aug 2019.In august 2019, the improved steam generator design was introduced for newly manufactured devices (flushers).The change of steam generator was related to improvement of the thermal protection (temperature limiter) which was changed from an automatic reset to manual reset.The previous design of thermal protection has an automatic reset, which means that in case of overheating, the thermal protection will turn off the steam generator at a set point, then automatically turns on if the temperature drops by 10k below the set point.This can result in a significant amount of switching on and off, which as a result could lead to a malfunction - possible overheating.The design of thermal protection was improved and now has a manual reset, which means that in case of overheating, the thermal protection will turn off the steam generator at a set point and will not turn on.Only trained service technician can restore the device to normal operation.In addition, the service technician performs a quality check to verify whether it meets design specifications.The complaint history review was performed for the involved typhoon flusher (serial number (b)(4).The device was under an arjo service contract, and was regularly maintained.The last maintenance was performed on (b)(6) 2021.The history of service repairs conducted on this flusher revealed that the burnt part ¿ a steam generator - had been replaced on (b)(6) 2020.Following the typhoon service manual it is recommended to perform maintenance for flushers at regular intervals.For the steam generator part ¿ every year / 10,000 cycles: ¿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.¿ based on the information we gathered and analysis performed, we determined that the fire occurred due to overheated steam generator.This situation might occur only in case of thermal protection malfunction.Following the investigation performed and analysis results, we came to the conclusion that the event reported (ignition of the device) was caused by the overheating of the previous design steam generator (manufactured prior to aug 2019) in which the thermal protection did not cut off the power.To sum up, according to the gathered information the involved typhoon flusher was used, when the event occurred.Based on the performed evaluation of the device, the 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 due to indication of a fire occurrence.

• Brand Name: TYPHOON
• Type of Device: WASHER OF BODY WASTE RECEPTACLES
• Manufacturer (Section D): GETINGE DISINFECTION AB; ljungadalsgatan 11, vaxjo kronobergs lan [se-07]; vaxjo 35115 ; SW 35115
• Manufacturer (Section G): GETINGE DISINFECTION AB; ljungadalsgatan 11, vaxjo kronobergs lan [se-07]; vaxjo 35115 ; SW 35115
• Manufacturer Contact: katarzyna bobrow ; ks. wawrzyniaka 2; komorniki 62-05-2 ; PL 62-052 ; 668046472
• MDR Report Key: 13853998
• MDR Text Key: 287659696
• Report Number: 3007420694-2022-00041
• Device Sequence Number: 1
• Product Code: FLH
• Combination Product (y/n): N
• Reporter Country Code: CA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: User Facility,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date: 10/20/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/22/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Model Number: SP6000
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 02/22/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/25/2009
• 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
• Patient Outcome(s): Other