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

Model Number	8668
Medical Device Problem Code	Installation-Related Problem (2965)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/17/2023
Type of Reportable Event	Malfunction
Event or Problem Description
On 17th february, 2023 getinge became aware of an issue related to the washer disinfector with the model name 8668.As it was stated, the incorrect detergent dosing and final rinse were set on the device for one of the programs.The washer disinfector was used in this state without any correction of the program settings for about 1 year.We have no information about any adverse outcome due to the issue, however we decided to report the issue in abundance of caution, that any improperly cleaned loads used for patients¿ treatment could be the source of infection.
Additional Manufacturer Narrative
Additional information will be provided following the conclusion of the investigation.Device not returned to the manufacturer.
Event or Problem Description
Manufacturer's reference number: (b)(4).
Additional Manufacturer Narrative
On 17th february, 2023 getinge became aware of an issue with four 86-series washer disinfectors with the model¿s name: 8668 and serial numbers: (b)(6).The reported issue is related to incorrect dosing of the getinge clean universal detergent, which resulted from incorrect parameters set in the device's program.Regular inspections were performed on these devices, but incorrect dosing was not noticed.It was indicated to getinge that the washer disinfectors were used in this state without any correction of the program setting, for about 1 year.With the complaint at hand there was no allegation about any adverse outcome, however we decided to report the issue based on the potential, that any improper cleaned instruments, as a result of detergents not dosed correctly during the process, could be used to the patients¿ treatment and lead to the cross-infection.Trend review of customer product complaints with the same issue involved on this type of devices reported within the last 5 years was performed but did not provide any signals that would warrant further scrutiny.During investigation course it was confirmed that the problem is connected to a validation, which was not performed correctly by the service technician and the most probably root cause was established as a service and business issue.In order to avoid such incidents in the future, the technician was retrained.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.

• 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: 16458679
• Report Number: 9616031-2023-00008
• Device Sequence Number: 20461759
• Product Code: MEC
• UDI-Device Identifier: 07340153700277
• UDI-Public: (01)07340153700277
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• 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): 03/01/2023

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: 02/17/2023
• Supplement Date Received by Manufacturer: 01/04/2024
• Initial Report FDA Received Date: 03/01/2023
• Supplement Report FDA Received Date: 01/05/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 10/17/2018
• Is the Device Labeled for Single Use? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown