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

Model Number	8668
Medical Device Problem Codes	Detachment of Device or Device Component (2907); Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/19/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Additional information will be provided following the conclusion of the investigation.Device not returned to the manufacturer.
Event or Problem Description
On (b)(6) 2022 getinge received an information about the event, which was related to the 86-series washer disinfector with the model name 8668.As it was stated, wash carts almost fell from the trolley to the floor.The initial customer allegation was the lack of elements on the stops of the wash cart trolleys.A getinge technician confirmed during an on-site inspection that several trolleys were missing stop pins.The device has a cotter pin instead of a clip to hold the pin.The cart stop assembly has been replaced on all wash cart trolleys.The device with trolleys was returned for use in a fully operational condition.There was no allegation about any injury or damage, however we decided to report the issue based on a potential as wash cart falling to the floor could bring a hazardous situation for the operator and lead to serious injury if the situation was to reoccur.
Additional Manufacturer Narrative
Getinge received an information about the event, which was related to the 86-series washer disinfector with the model's name: 8668.As it was stated, wash carts almost fell from the trolley to the floor.The initial customer allegation was the lack of elements on the stops of the wash cart trolleys.A getinge technician confirmed during an on-site inspection that several trolleys were missing stop pins.The device has a cotter pin instead of a clip to hold the pin.The cart stop assembly has been replaced on all wash cart trolleys.The device with trolleys was returned for use in a fully operational condition.There was no allegation about any injury or damage, however we decided to report the issue based on a potential as wash cart falling to the floor could bring a hazardous situation for the operator and lead to serious injury if the situation was to reoccur.The findings of the investigation enable us to conclude that the issue is connected with design of the stop pin component.Consequently, a new design for the stop pins was implemented, and the problem was effectively resolved.When the incident occurred, the product was directly involved, and out of specification.The device was not being used for treatment or diagnosis of the patient.We currently do not have any information that would warrant further action towards the device manufacturing or devices on the market, however as per our complaint handling processes 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: 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: 15657262
• Report Number: 9616031-2022-00022
• Device Sequence Number: 5882391
• Product Code: MEC
• UDI-Device Identifier: 07340153700277
• UDI-Public: (01)07340153700277
• Combination Product (Y/N): N
• Initial Reporter State: IN
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: User Facility,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 10/24/2022

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
• Device Catalogue Number: S-86682003-CTOM
• 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: 10/19/2022
• Supplement Date Received by Manufacturer: 09/20/2024
• Initial Report FDA Received Date: 10/24/2022
• Supplement Report FDA Received Date: 09/27/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 02/20/2019
• Is the Device Labeled for Single Use? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown