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

Model Number SP1100AR001

Device Problems Use of Device Problem (1670); Defective Component (2292)

Patient Problem Blister (4537)

Event Date 08/01/2023

Event Type  malfunction  

Event Description

The nurse got scalded (not serious) after opening the flusher's door.The device was diplaying code which warns about possible hot items.Device inspection showed that the external cooling valve needed replacement.The nurse opened the tornado flusher doors, although the warning was displayed on the device about hot items.Initial investigation indicates that the nurse sustained small blister from touching hot bedpan.The code was displayed on the device which states that the goods inside the flusher maybe be above 60 degree celsius.Currently available instruction for use warns: "the goods may be hot at the end of the program.If the temperature of the goods is above 60 degrees celsius, the display shows u7".

Manufacturer Narrative

The investigation completion is ongoing.A follow-up report will be submitted upon completion of the investigation.

Manufacturer Narrative

The nurse sustained not serious burn (blisters) after opening the flusher's doors and touching the bedpan which was inside the flusher.At the end of the cycle, if the items inside the flusher are hot, the system will display the warning code u7.In this complaint the error u7 and the red led was displayed.Product operating instruction 5015511-00 warns that "at the end of the program, the items may be hot.If the items are hotter than 60 degree celcius, u7 is shown on the display"; "if the red lamp lights up at o, disinfection is aborted because the temperature is too low or because of another error.An error code is displayed." the products' control measures were working as intended.When the device was inspected it was found that the valve/nozzle which washes the flashers' wall after disinfection and thus cools the walls and interior of the chamber, was defective.The cooling process took longer than it could be expected by the user.The valve was replaced.The device failed because the valve was defective, however the defect is unlikely to lead to a serious injury.The cause of non serious injury sustained by the user is related to the opening of flusher door when items were not yet cooled down, and despite warning displayed on the device.In summary, the device failed to meet its performance specification, the device was involved in the non-safety related even, since the user opened the flusher doors and touched the hot items sustaining non serious injury.There was no serious injury in the past, within the reviewed time frame, we have not found another complaint where the user would open the flusher doors despite warnings, therefore this complaint is concerned a singular occurrence.It is believed that future cases where user is opening the doors although the items are not cooled down, will not be considered a reportable scenario.

• 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: katarzyna bobrow ; ks. wawrzyniaka 2; komorniki 62-05-2 ; PL 62-052 ; 668046472
• MDR Report Key: 17735036
• MDR Text Key: 323316705
• Report Number: 3007420694-2023-00219
• Device Sequence Number: 1
• Product Code: FLH
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 10/13/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/13/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: SP1100AR001
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 08/16/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/06/2008
• 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
• Patient Sex: Female