MAUDE Adverse Event Report: GETINGE DISINFECTION AB 86-SERIES; DISINFECTOR, MEDICAL DEVICES

Model Number	8668
Medical Device Problem Code	Device Fell (4014)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/29/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Additional information will be provided following the conclusion of the investigation.H3 other text : device not returned to the manufacturer.
Event or Problem Description
On february 29, 2024 getinge became aware of an issue related to the automation loading system with the model name: ags 2.0.The getinge ags 2.0 is not registered as a medical device, however upon the situation occurrence it was used with the four medical devices - 86-series washer disinfectors with the model name: 8668.As it was stated, the rack almost fell on the floor.Gathered information allowed us to establish that device was restarted and it was returned to the service in full working condition.There was no allegation of injury however, we decided to report the issue based on a potential as a rack falling to the floor could bring a hazardous situation for the operator and lead to serious injury if the situation reoccurs.
Event or Problem Description
Manufacturer's reference number: (b)(4).
Additional Manufacturer Narrative
On february 29 2024, getinge became aware of an issue related to the automation loading system with the model name: ags 2.0.The getinge ags 2.0 is not registered as a medical device, however upon the situation occurrence it was used with the four medical devices - 86-series washer disinfectors with the model name: 8668 what makes the incident reportable to the competent authorities.As it was stated, the rack almost fell on the floor.We decided to report the issue based on a potential that if a situation was to reoccur there was a potential for a serious injury.The ags mechanisms was working correctly according to the technician, however the trolley that was used was not secured correctly.This allowed the ags to push the cart onto the trolley whilst simultaneously pushing the cart away, causing the issue.Where the instructions followed ("ags manual outtake").The issue could have been avoided.When the event occurred, the getinge device was directly involved and meet its specification.Upon the event occurrence the device was not being used for patient treat mentor diagnosis.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: 86-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: tina evancho ; ljungadalsgatan 11; vaxjo
• MDR Report Key: 18884316
• Report Number: 9616031-2024-00011
• Device Sequence Number: 7550857
• Product Code: MEC
• UDI-Device Identifier: 07340153700277
• UDI-Public: (01)07340153700277
• Combination Product (Y/N): N
• Initial Reporter Country: SP
• 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): 03/12/2024

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: 8668
• 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: 02/29/2024
• Supplement Date Received by Manufacturer: 09/12/2024
• Initial Report FDA Received Date: 03/12/2024
• Supplement Report FDA Received Date: 09/12/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/01/2016
• Is the Device Labeled for Single Use? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown