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

Model Number SP1000

Device Problem Fire (1245)

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

Event Type  malfunction  

Event Description

Arjo was notified about an event regarding tornado flusher.It was indicated that tornado get in fire.No patient or employees were involved.No one was injured.

Manufacturer Narrative

(b)(4).The device was evaluated by an arjo representative on site.This inspection and photo evidence provided revealed that the traces of fire are around the cables.Analysis of collected information is ongoing to provide the final conclusions.

Manufacturer Narrative

Arjo was notified about an event regarding tornado flusher.It was indicated that tornado set on fire.No patient or employees were involved.No one was injured.The device was evaluated by an arjo representative on site.This inspection and photo evidence provided revealed that the traces of fire were around the wire harness and power cord.Further evaluation performed by the manufacturer confirmed that the cause of the ignition was an electrical short from around the wiring harness.The wires at this location were melted, burned and damaged.Other damages were caused by heat or smoke from a flame source.It was determined that all other wires were intact - no signs of breakage, tearing.Due to the damages caused by the device ignition around the wire harness, the exact location of the electrical short could not be confirmed.In summary, it can be hypothesized that the wiring harness damage was caused by years of usage (vibration, banging on doors, the wires rubbed against the edge of the mounting plate etc.).The electrical components including wires, connector plugs are exceptionally exposed to wear, what is increased with wet and warm environment inside flusher.According to the tornado user manual (6001314502), 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.During the preventive maintenance the qualified technician should check yearly "electrical cables and connection points to avoid personal injury as well as damage to the machine itself." the involved tornado flusher device was in use for 17 years when the event occurred.Based on the information gathered, the tornado device was serviced by arjo occasionally, upon the customer request and according to the order.According to the information collected and evaluation performed it can be hypothesized that the fire was triggered as a consequence of wear wires, which in consequence contributed to an electrical short and ignition of the device.In summary, according to the gathered information the involved tornado flusher was used, when the event occurred.Based on the performed evaluation of the device, the wires harness were burned due to an electrical short occurrence, 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

The device was evaluated by the manufacturer and it was confirmed that the traces of fire are around the cables.Analysis of collected information is ongoing to provide the final conclusions.

• Brand Name: TORNADO
• 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: justyna kielbowska ; ks. wawrzyniaka 2; komorniki 62-05-2 ; PL 62-052 ; 883337089
• MDR Report Key: 15146664
• MDR Text Key: 297051058
• Report Number: 3007420694-2022-00126
• 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
• Report Date: 09/08/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/02/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Model Number: SP1000
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 07/04/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/28/2005
• 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