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

Model Number	56M
Medical Device Problem Codes	Device Damaged Prior to Receipt by User (1570); Tear, Rip or Hole in Device Packaging (2385)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/27/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Additional information will be provided following the conclusion of the investigation.
Event or Problem Description
On july 18th, 2024 getinge became aware of of an issue with getinge disinfection ab washer disinfector aquadis 56m.The issue is linked with packaging of the aquadis 56m.As it was stated, machine outer packaging was torn and the pallet was broken.Aquadis 56m has slipped out from the original place in pallet due to legs being not tied or screwed to the pallet.The customer claims that the glass door was not covered.The unit is damaged with broken glass, dented handle, dented plate, missing leg plate, bent programmable logic controller plate and machine lower panel dislocated.There was no injury.Nevertheless, we decided to report the issue in abundance of caution, as we cannot confirm that similar event would not contributed to the serious injury if reoccurs.
Additional Manufacturer Narrative
Getinge became aware of an issue with getinge disinfection ab washer disinfector aquadis 56m with the serial number: (b)(6).The unit was manufactured on 11th june 2024.The issue is linked with packaging of the device.As it was stated, machine outer packaging was torn and the pallet was broken.Aquadis 56m has slipped out from the original place in pallet due to legs being not tied or screwed to the pallet.There was no injury.Nevertheless, we decided to report the issue in abundance of caution, as we cannot confirm that similar event would not contributed to the serious injury if reoccurs.The root cause has been defined as transport issue, as the load tilt indicator showed that shipment has been mishandled by carriers during shipping.The aquadis 56 washer disinfector was directly involved in the event and meet its specification.Upon the event occurrence the device was not being used for patient treatment.We initially decided to report the issue.Later on, and after receiving additional information, it was established that no serious injury occurred in this situation.Taking under consideration information collected to date it was stated that problem with slippery of the device from the pallet not falling under vigilance reporting requirements.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: 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: maria elovsson ; ljungadalsgatan 11; vaxjo
• MDR Report Key: 19836295
• Report Number: 9616031-2024-00029
• Device Sequence Number: 6648595
• Product Code: MEC
• UDI-Device Identifier: 07340153710351
• UDI-Public: 7340153710351
• Combination Product (Y/N): N
• Initial Reporter Country: MY
• 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): 07/26/2024

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
• Device Model Number: 56M
• Device Catalogue Number: UNKNOWN
• 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: 07/18/2024
• Supplement Date Received by Manufacturer: 01/20/2025
• Initial Report FDA Received Date: 07/26/2024
• Supplement Report FDA Received Date: 01/20/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/11/2024
• Is the Device Labeled for Single Use? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown