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

Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/10/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Additional information will be provided following the conclusion of the investigation.
Event or Problem Description
On (b)(6) 2024 getinge received the information about the event which was related to the loading trolley.The loading trolley involved in the adverse event worked with two aquadis 56 washer disinfectors.As it was stated the wheel has come loose and the employee had to hold the load when it came out of the washer disinfector because it fell on operator.There was no serious injury reported, however we decided to report the issue based on a potential as load falling off the trolley could bring a hazardous situation for the operator and lead to a serious injury if the situation was to reoccur.
Event or Problem Description
Manufacturer's reference number: (b)(4).
Additional Manufacturer Narrative
On 10th june, 2024 getinge received the information about the event which was related to the loading trolley.As it was stated an employee experienced an incident where caster came loose from the cart.The employee had to support the load when it fell from the washer.The most probably root cause is lack of tightening and loctite 222 (low-strength thread locker that allows the adjustment of screws including countersunk head screws and set screws) on the screw, as specified on the assembly drawing, during assembly work at the supplier.The supplier has been informed about the manufacturer¿s investigations findings.When the event occurred, the trolley was directly involved and not meet its specification.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 decided to report the issue based on a potential as a similar event could contributed to the injury if reoccurs.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.

• 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: 19699388
• Report Number: 9616031-2024-00026
• Device Sequence Number: 15367488
• Product Code: MEC
• UDI-Device Identifier: 07340153710344
• UDI-Public: (01)07340153710344
• 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): 07/08/2024

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
• Operator of Device: Health Professional
• 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: 06/10/2024
• Supplement Date Received by Manufacturer: 11/15/2024
• Initial Report FDA Received Date: 07/09/2024
• Supplement Report FDA Received Date: 11/15/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/08/2023
• Is the Device Labeled for Single Use? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown