MAUDE Adverse Event Report: GETINGE DISINFECTION AB 91E-SERIES; DISINFECTOR, MEDICAL DEVICES

Model Number	9128E
Medical Device Problem Code	Contamination /Decontamination Problem (2895)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/08/2023
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 december 8th, 2023 getinge became aware of an issue with the 91e-series washer disinfector, with the model name 9128e.As it was stated debris was on the instuments.There was no alarm on the device.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.
Event or Problem Description
Manufacturer's reference number: (b)(4).
Additional Manufacturer Narrative
On december 8th, 2023 getinge became aware of an issue with the 91e-series washer disinfector, with the model's name 9128e and serial number: (b)(6).The unit was manufactured on 28th march 2023 and installed on 31st march 2023.Initial allegation pointed to present debris on instruments.After inspection, the technician did not detect the presence of debris during operation of the device.There was no injury reported, however it was decided to report this issue based on the potential risk as a using unclean instruments on patient might lead to an adverse outcome.After our initial report and based on the information collected during the investigation it was established that all the affected instruments were noticed by the customer and then reprocessed.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 triggered further scrutiny.Taking under consideration information collected to date it was stated that problem with detected debris on instrument is not falling under vigilance reporting requirements and the hazard scenario as found in this complaint would, if detected earlier, not to be reported to the competent authorities.It was established that the getinge product was not directly involved with the reported event and meet its specification.None of the provided information indicates that upon the event occurrence the device was being used for patient treatment or diagnosis.We believe that devices in the market are performing correctly overall.Given the circumstances and the fact that there is no apparent trend in complaints of this nature, we shall continue to monitor for any further events of this nature.

• Brand Name: 91E-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: 18449613
• Report Number: 9616031-2024-00001
• Device Sequence Number: 7155031
• Product Code: MEC
• UDI-Device Identifier: 07340153710061
• UDI-Public: (01)07340153710061
• Combination Product (Y/N): N
• Initial Reporter State: TX
• 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): 01/05/2024

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: 9128E
• 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: 12/08/2023
• Supplement Date Received by Manufacturer: 08/08/2024
• Initial Report FDA Received Date: 01/05/2024
• Supplement Report FDA Received Date: 08/08/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 03/28/2023
• Is the Device Labeled for Single Use? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown