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

Model Number	CM320-4
Medical Device Problem Codes	Fire (1245); Overheating of Device (1437)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/26/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Additional information will be provided following the conclusion of the investigation.
Event or Problem Description
Getinge received information that the heating wire in the ultrasonic cavity for this device turned red during operation.Upon inspection, it was found that the shorting wire of the heating element had burnt out and required replacement.It was reported that the fuse was not impacted.There were no injuries reported.
Event or Problem Description
Manufacturer's reference number: (b)(4).
Additional Manufacturer Narrative
Getinge received information that the heating wire in the ultrasonic cavity for this device turned red during operation.Upon inspection, it was found that the shorting wire of the heating element had burnt out and required replacement.The most probable cause of overheating is increased contact resistance at screw connections possibly due to loose connection/insufficient tightening or oxidation of contact surfaces; however, this could not be confirmed due to missing components; the returned heating elements did not include the associated screw connections, preventing detailed verification.At this stage, no further action towards the manufacturing process or marketed devices is warranted.However, getinge will continue to closely monitor customer feedback and field performance of the device for any future information that may require additional action.
Additional Manufacturer Narrative
Further investigation will be performed under the corrective and preventive action.Field h6 (medical device ¿ problem code) was updated.
Event or Problem Description
Manufacturer's reference number: (b)(4).

• 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: emelie szabo ; ljungadalsgatan 11; vaxjo
• MDR Report Key: 23776775
• Report Number: 9616031-2025-0000011
• Device Sequence Number: 18656357
• 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
• Reporter Type: Manufacturer
• Report Source: Foreign,User Facility,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 07/22/2026

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: CM320-4
• Device Catalogue Number: CM320WUWD-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: 11/27/2025
• Supplement Date Received by Manufacturer: 06/11/2026; 06/23/2026
• Initial Report FDA Received Date: 12/11/2025
• Supplement Report FDA Received Date: 06/12/2026; 07/22/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/30/2022
• Is the Device Labeled for Single Use? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown