MAUDE Adverse Event Report: GETINGE DISINFECTION AB 88-SERIES; DISINFECTOR, MEDICAL DEVICES

Model Number	88-5
Medical Device Problem Code	Fire (1245)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/19/2024
Type of Reportable Event	Malfunction
Event or Problem Description
On september 19th, 2024 getinge became aware of an issue with the 88-series washer disinfector with the model name: 88-5.As it was stated, the washer disinfector caught on fire after all employees had gone home.So far, we have not been informed about any serious injury as a consequence of reported issue, however we decided to report the issue in abundance of caution and based on the potential for serious injury if the situation was to reoccur.
Event or Problem Description
Manufacturer's reference number: (b)(4).
Additional Manufacturer Narrative
On september 19th, 2024, getinge became aware of an issue with the 88-series washer disinfector, model name: 88-5 with the serial number (b)(6).The unit was manufactured on 6th february 2019 and installed on 18th may 2019.As reported, the washer caught on fire.Despite our best efforts, it was unable to establish the root cause of the issue.The machine is currently held by a third-party laboratory for their independent analysis, and the cpu card is damaged, preventing from extracting critical data needed to validate our theories.A collaborative investigation was conducted involving on-site service technicians and internal experts to identify the cause of the issue.Initial assessments and troubleshooting were performed to gather as much information as possible about the event.However, the machine was subsequently transferred to a third-party laboratory for their independent analysis, limiting ability to conduct further investigation.At this stage, the cause of the issue remains undetermined due to the unavailability of the machine for further investigation and the irreparable damage to the cpu card.Trend review of customer product complaints with the same issue involved on this type of devices reported within the last 5 years was performed but did not provide any signals that would warrant further scrutiny.When the event occurred, the device was directly involved and not meet its specification.Upon the event occurrence the device was not being used for patient treatment.We currently do not have any information that would warrant further action towards the device manufacturing or devices on the market, however getinge will continue to monitor the customer experiences with the device for any future information.
Additional Manufacturer Narrative
On september 19th, 2024, getinge became aware of an issue with the 88-series washer disinfector, model name: 88-5 with the serial number (b)(6).The unit was manufactured on 6th february 2019 and installed on 18th may 2019.As reported, the washer caught on fire.The affected washer was removed and has been taken to a third-party laboratory for analysis.The fire was determined to have originated in the dosing equipment area.Recurring electrical malfunctions associated with the third party dosing system were reported.The incident was classified as an unauthorized modification of the equipment, since a third-party dosing system had been connected to the 88-series washer-disinfector without prior approval.Trend review of customer product complaints with the same issue involved on this type of devices reported within the last 5 years was performed but did not provide any signals that would warrant further scrutiny.When the event occurred, the device was directly involved and not meet its specification.Upon the event occurrence the device was not being used for patient treatment.We currently do not have any information that would warrant further action towards the device manufacturing or devices on the market, however getinge will continue to monitor the customer experiences with the device for any future information.
Event or Problem Description
Manufacturer's reference number: (b)(4).

• Brand Name: 88-SERIES
• Common Device Name: DISINFECTOR, MEDICAL DEVICES
• Manufacturer (Section D): GETINGE DISINFECTION AB; ljungadalsgatan 11; vaxjo
• Manufacturer (Section G): GETINGE DISINFECTION AB; ljungadalsgatan 11; vaxjo
• Manufacturer Contact: emelie szabo ; ljungadalsgatan 11; vaxjo
• MDR Report Key: 20276739
• Report Number: 9616031-2024-0000031
• Device Sequence Number: 7934223
• Product Code: MEC
• UDI-Device Identifier: 07340153700109
• UDI-Public: (01)07340153700109
• Combination Product (Y/N): N
• Initial Reporter State: MN
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: User Facility,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 09/23/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: 88-5
• Device Catalogue Number: 88-303-CTOM
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/19/2024
• Supplement Date Received by Manufacturer: 02/25/2025; 11/06/2025
• Initial Report FDA Received Date: 09/23/2024
• Supplement Report FDA Received Date: 02/25/2025; 11/28/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 02/04/2019
• Is the Device Labeled for Single Use? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown