MAUDE Adverse Event Report: GETINGE DISINFECTION AB CM320-SERIES; DISINFECTOR, MEDICAL DEVICES

Model Number	CM320-3
Medical Device Problem Code	Fire (1245)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/11/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Getinge became aware of an incident involving the cm320-series washer disinfector, model cm320-3, serial number: (b)(6).The washer disinfector was manufactured on 26th november, 2021 and installed in the facility on (b)(6) 2023.Investigation has been performed, based on the new information collected and the evaluation of the returned components, it became available that the device malfunction caused or contributed to incident.The factory investigation concluded that adverse event was caused by a poor electrical connection or insufficient tightening of the heating elements, combined with the use of an element cover (part number: 6027880201) that did not meet appropriate fire classification standards.Following the investigation conclusions, at the time of the incident, the affected device was directly involved and did not meet its specifications.The device was not in use for patient treatment or diagnosis.Based on the investigation findings corrective and preventive action#: (b)(4) has been initiated.
Event or Problem Description
Getinge became aware of an issue involving the cm320-series washer disinfector.Initial information indicated that a fire occurred upon powering on the equipment in the morning.According to the information provided by the sales and service units, the cause of the incident could not be conclusively determined at the time.The fire appears to have originated in the area between the ultrasound chamber (second chamber) and the cleaning and disinfection chamber (third chamber), with visible damage observed beneath the third chamber.The facility sprinkler system was activated and functioned as intended, which successfully contained the fire.At the time of that initial information received the cause of the fire was not known to be device related.An investigation was initiated, and the return of relevant parts was requested to support cause analysis.At the time of this report, no serious injuries have been reported in connection with the incident, however we have decided to report the issue based on the potential of harm if the issue was to reoccur.

• Brand Name: CM320-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: maria elovsson ; ljungadalsgatan 11; vaxjo
• MDR Report Key: 22083718
• Report Number: 9616031-2025-0000005
• Device Sequence Number: 6926338
• Product Code: MEC
• UDI-Device Identifier: 07340153700192
• UDI-Public: (01)07340153700192
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,User Facility,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 05/23/2025

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
• Device Model Number: CM320-3
• Device Catalogue Number: CM320WWD-CTOM
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/29/2025
• Initial Report FDA Received Date: 05/26/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/26/2021
• Is the Device Labeled for Single Use? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown