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

Model Number SP6000AR009

Device Problem Fire (1245)

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

Event Date 04/29/2023

Event Type  malfunction  

Manufacturer Narrative

Please note that previous medwatch reports for this product may have been submitted under the following registration numbers: 9616031, 3004147784, 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.Process of analyzing information is ongoing.Additional information will be provided upon conclusion of the investigation.

Event Description

Arjo has been notified of an incident with a typhoon flusher.It was indicated that the typhoon flusher had caught fire.Nurses noticed smoke and flames at the bottom door of the flusher.The ignition was quickly contained.No one was injured and there was no other damage to the facility.

Manufacturer Narrative

Process of analyzing information is ongoing.Additional information will be provided upon conclusion of the investigation.

Manufacturer Narrative

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

Manufacturer Narrative

Arjo has been notified of an incident with a typhoon flusher.It was indicated that the typhoon flusher had caught fire.Nurses noticed smoke and flames at the bottom door of the flusher.The ignition was quickly contained.No one was injured and there was no other damage to the facility.The steam generator was returned to the manufacturer for further evaluation in order to determine the root cause of the alleged fire.According to the information gathered and the assessment performed, it can be hypothesised that the cause of the fire was the steam generator part malfunction - the clamp unsealed over time causing the water leak.This consequently contributed to the overheating of the steam generator and ignition of the device.In addition, it is suspected that the lack of insulation around the steam generator during the event (which, however, has not been confirmed) might also have contributed to faster overheating inside the flusher.At the time of the event, the typhoon flusher was in use for 12 years.The repair history performed on this flusher revealed that the steam generator had not been replaced since manufacturing.According to the typhoon instruction for use (6001269002), a periodic maintenance and system testing must be performed to ensure safety and the machine's proper operation: 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.¿ arjo device failed to meet its performance 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: justyna kielbowska ; ks. wawrzyniaka 2; komorniki 62-05-2 ; PL 62-052 ; 883337089
• MDR Report Key: 17017942
• MDR Text Key: 316089831
• Report Number: 3007420694-2023-00116
• Device Sequence Number: 1
• Product Code: FLH
• Combination Product (y/n): N
• Reporter Country Code: FR
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: User Facility,Company Representative
• Reporter Occupation: Biomedical Engineer
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 08/23/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/30/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Model Number: SP6000AR009
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/02/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/23/2011
• 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