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

Model Number SP6000AR003IT01

Device Problem Fire (1245)

Patient Problem No Patient Involvement (2645)

Event Date 05/05/2020

Event Type  Injury  

Manufacturer Narrative

(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).According to the results of inspection, the device was confirmed to be burned.It was suspected that the device was incorrectly maintained.It was not serviced by the arjo, but by the 3rd party service provider.The unit was approximately 20 years old.The investigation is on-going and further information will be provided in the next report.

Event Description

Arjo was notified about an incident with involvement of typhoon flusher.It was stated that the device burned.No patient involvement or injury occurrence were reported.

Manufacturer Narrative

Arjo was notified about an incident with involvement of typhoon flusher.It was stated that the device caught fire and burned.The customer facility personnel used fire extinguisher to stop it.No patient involvement or injury occurrence were reported.The involved device was removed from use due to unusable condition and was evaluated by the arjo representative.According to the results, the washer was significantly damaged and clear conclusions were not possible to be drawn.However, the analysis of damages, allowed to determine that fire probably began within the steam generator area.The potential cause was deemed to be a combination of defective electrical wiring, drainage, heat insulation of washing chamber and steam generator.The device in question was not maintained by arjo, but by a 3rd party company.The date and scope of the last service performed for this device was unknown.It was suspected that the involved device was incorrectly maintained.This was based on the inspection of the other flushers present at the facility, but not involved in the incident.These devices were found to be in unsatisfactory condition and not according to the manufacturer¿s specification due to not followed maintenance requirements.Please note that the same facility reported similar incident on different typhoon washer.Based on the information made available to date, there was no link between these cases.The second incident was reported by arjohuntleigh ab under the manufacturer report number 3007420694-2020-00087.The periodic maintenance and system testing of the typhoon flusher must be performed to ensure safety and the machine¿s good operation.Periodic maintenance is performed in the aim of ensuring that the machine¿s proper operation and safety are maintained.Based on the typhoon technical manual (503900300_en_revb) it is recommended that the maintenance operations should be performed in 1-2 year intervals and according to the action schedule including, for example, required checks and regular replacements.Moreover, the same document states that the maintenance must only be done by authorized personnel.Typhoon instructions for use (6001269002_2) also includes a requirement stating that maintenance personnel must have completed training through the marketing organization of arjo.Taking into account the information obtained upon the investigation, it is considered likely that the manufacturer¿s maintenance procedure and schedule were not followed by the customer facility.According to the typhoon ifu the equipment¿s service life is ten years.The claimed device was manufactured over 18 years before the event occurred.Therefore, the device was used over 8 years longer than recommended.Therefore, the probable root cause was considered related to the incorrect preventive maintenance and the device used after its recommended lifetime.In summary, according to the gathered information the involved typhoon flusher was most probably used, when the event occurred.Based on the performed evaluation of the device, its components were burnt and was in overall unusable condition.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 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
• MDR Report Key: 10091297
• MDR Text Key: 192148068
• Report Number: 3007420694-2020-00088
• 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: company representative,user f
• Type of Report: Initial,Followup
• Report Date: 06/22/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/27/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: SP6000AR003IT01
• Was Device Available for Evaluation?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other