MAUDE Adverse Event Report: GETINGE DISINFECTION AB AQUADIS 56; DISINFECTOR, MEDICAL DEVICES

Model Number	56M
Medical Device Problem Code	Device Emits Odor (1425)
Health Effect - Clinical Codes	Sore Throat (2396); Cough (4457); Eye Pain (4467)
Date of Event	07/16/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
Getinge has been aware about a chemical odor from washer disinfector aquadis 56-series, model name 56m.The odor led to health symptoms reported by staff including coughing, sore throat, and breathing issues.Several individuals required medical testing and treatment.In response, the unit was taken out of service.
Additional Manufacturer Narrative
Additional information will be provided following the conclusion of the investigation.
Additional Manufacturer Narrative
Getinge disinfection ab (getinge) received information that the washer door locking body on the aquadis 56m cracked.According to the getinge technician, due to the crack in the plastic combined with heat from the cycle temperature activated a reaction resulting in a release of strong chemical odour.Following exposure to the odour during a wash cycle, staff members reported health symptoms including coughing, sore throat, breathing and swallowing difficulties and burning eyes.Some individuals underwent medical evaluation and treatment, including x-ray examination, blood tests, and prescription of inhalers (¿puffers¿).However, the full extent of exposure and possible health effects for all individuals remains unknown.The investigation determined that degradation of the polyoxymethylene (pom) door lock component was most likely caused by exposure to an external acidic and/or chlorinated chemical, which is inconsistent with approved process chemistry.Under such conditions (acidic environment and elevated temperature), pom may degrade and release formaldehyde, a known respiratory irritant.Based on the external laboratory analysis, it is concluded that a cleaning agent reacting with pom most likely have been applied to the door lock body located on the soil side of the affected unit.Therefore, the event is considered to be the result of user error.Parts have been replaced, device was repaired and put back in use, the odour was not present after the repair.The user has been informed regarding proper maintenance procedures for the device it has been additionally reported on march 20th 2026 that at the time of the incident, five persons were present in the room.As the full medical status of all individuals is not confirmed, and out of an abundance of caution, four additional reports are being submitted to comply with the requirement of one report per potentially exposed individual.The remaining four reports numbers related to this incident are: 9616031-2026-0000005 9616031-2026-0000004 9616031-2026-0000006 9616031-2026-0000007.
Event or Problem Description
Manufacturer's reference number: (b)(4).

• Brand Name: AQUADIS 56
• 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: 22673837
• Report Number: 9616031-2025-0000006
• Device Sequence Number: 3678069
• Product Code: MEC
• UDI-Device Identifier: 07340153710351
• UDI-Public: (01)07340153710351
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• 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): 04/03/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: 56M
• 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: 07/22/2025
• Supplement Date Received by Manufacturer: 04/03/2026
• Initial Report FDA Received Date: 07/31/2025
• Supplement Report FDA Received Date: 04/07/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/01/2023
• Is the Device Labeled for Single Use? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown