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

Model Number	CM320-5
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Codes	Abrasion (1689); Angioedema (4536)
Date of Event	04/08/2026
Type of Reportable Event	Malfunction
Event or Problem Description
A complaint was received by getinge regarding a cm320 washer-disinfector.During operation on the unit, an incident occurred in which the panel that sits above the screen/entry chamber 1 door (soiled side) detached from the unit and fell onto a staff member¿s arm.Initial inspection revealed one of the four hooks that secures the panel to the unit snapped off and appears bent.The staff member was able to complete their shift but subsequently reported the injury (graze and/or bruising and swelling), and called in sick for their next day scheduled shift.
Additional Manufacturer Narrative
Additional information will be provided following the conclusion of the investigation.

• 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: 24921725
• Report Number: 9616031-2026-0000010
• Device Sequence Number: 18709143
• Product Code: MEC
• UDI-Device Identifier: 07340153700192
• UDI-Public: (01)07340153700192
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• 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
• Report Date (Section B): 05/21/2026

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: CM320-5
• Device Catalogue Number: CM320K917
• 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: 04/09/2026
• Supplement Date Received by Manufacturer: 04/23/2026
• Initial Report FDA Received Date: 04/20/2026
• Supplement Report FDA Received Date: 05/21/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/27/2021
• Is the Device Labeled for Single Use? (Y/N): No
• Usage of Device: A
• Patient Sequence Number: 1
• Patient Sex: Unknown