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

Model Number SP6000AR009-FR

Device Problems Adverse Event Without Identified Device or Use Problem (2993); Temperature Problem (3022)

Patient Problem Burn(s) (1757)

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Additional information will be provided within the next report.

Event Description

Arjo was notified about an event with involvement of typhoon flusher.It was reported that a caregiver shut down the flusher in a middle of a cycle, then opened a device door and got burned.No further information regarding injury has been provided to date.

Manufacturer Narrative

The field device manufacture date was updated as value entered within the initial report was incorrect.Arjo was notified about an event with involvement of typhoon flusher.It was reported that a caregiver switched off the flusher device in a middle of a cleaning and disinfecting process using an isolator switch, then again turned the device on, opened a door and got burn during attempt to remove accessories from the chamber.No further details regarding injury assessment and applied treatment were made available.The involved device was removed from usage and evaluated by the qualified arjo representative.According to the results of inspection the error code [?]f7 - disinfection temperature not reached' was displayed, so the steam generator was replaced.It should be underlined that malfunction of this part did not directly contribute to the event (caregiver burned).It was also confirmed that when the caregiver opened the door the device was displaying information code [?]u7 - warning of high temperature for goods' as required.It appears that despite this warning the caregiver decided to open the door and remove accessories.Typhoon flusher-disinfector is intended for emptying, cleaning and disinfecting bedpans, urine bottles and other containers for human waste, including suction bottles and enables hygienic handling of these items.According to the information provided, the caregiver wanted to stop the ongoing cleaning and disinfecting process to remove the accessories from the flusher.To achieve that the caregiver used an main switch to disconnect the device from power supply and stop its functioning.Please note that the machine must have a lockable main/isolator switch for the electric power supply to be used e.G.In case of emergency.A switch is not required on machines fitted with an electric plug.In case of the power failure (or its intentional shutdown) during the process, the machine remains locked.When the power returns, the machine automatically restarts the interrupted process after a few seconds.The process can be aborted when the user once again selects the program or by intentional open of the door.Upon the performed investigation, it was determined that when the caregiver opened the door, the device was displaying information code 'u7 - warning of high temperature for goods' as required.According to the typhoon user manual (ifu; 503888900 rev.A): "the goods may be hot at the end of the program.If the goods are warmer than 60 degrees celsius, u7 appears in the display." please note that the user should read the product manual (ifu) and be aware of its guidelines and warnings, such as the one mentioned above.Based on the performed inspection, although the device's steam generator was found to be defective, this malfunction did not directly cause the injury.Our investigation showed that there was insufficient caution when the caregiver opened a door of the machine.In summary, the device was not according to the manufacturer's specification as there was malfunction detected during the evaluation.The device was used for accessories cleaning, when the event occurred.This complaint was decided to be reported to the competent authorities due to indication that caregiver sustained an injury.

• Brand Name: TYPHOON
• Type of Device: WASHER OF BODY WASTE RECEPTACLES
• Manufacturer (Section D): GETINGE DISINFECTION AB; ljungadalsgatan 11; vaxjo, vaxjo kronobergs ian [se-07] 35115 ; SW 35115
• MDR Report Key: 8661886
• MDR Text Key: 147323498
• Report Number: 3007420694-2019-00089
• 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: 06/28/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/03/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Model Number: SP6000AR009-FR
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 06/28/2019
• Distributor Facility Aware Date: 05/21/2019
• Device Age: 8 YR
• Event Location: Hospital
• Date Report to Manufacturer: 06/28/2019
• Date Manufacturer Received: 05/21/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other