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

Model Number	9125E
Medical Device Problem Code	Device Fell (4014)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/19/2024
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 (b)(6) 2024 getinge became aware of an issue with 91e-series washer disinfector.A customer allegation was related to the door issue.As it was stated, load (a container) had fallen off the loading cart and obstructed the door.No getinge technician service visit was required.Machine returned to normal working condition.So far, we have not been informed about any adverse consequences of reported issue, however we decided to report the issue based on the potential as the load falling to the ground may result in a serious injury if the situation was to reoccur.
Additional Manufacturer Narrative
On january 19th, 2024 getinge became aware of an issue with the 91e series washer disinfector, with the model name 9125e and serial number (b)(6).The washer disinfector was manufactured on 27th september, 2019.The reported issue is related to container falling from the cart to the floor and obstructed the door.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.Based on the investigation and information provided by the subject matter expert, the device was found to be working according to specification and the issue was resolved by hospital¿s employees.The root cause of the issue is most likely associated with incorrect use of the product - user error ¿ customer did not load the trolley correctly according to user manual.When the incident occurred, the product was directly involved.The device was not being used for treatment or diagnosis of the patient.There was no injury reported until date, nevertheless we decided to report the issue based on the potential as this kind of malfunction could lead to a serious injury.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: 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: 18612193
• Report Number: 9616031-2024-00002
• Device Sequence Number: 2466513
• Product Code: MEC
• UDI-Device Identifier: 07340153710047
• UDI-Public: (01)07340153710047
• 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): 01/31/2024

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: 9125E
• Device Catalogue Number: UNKNOWN
• 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: 01/19/2024
• Supplement Date Received by Manufacturer: 06/27/2024
• Initial Report FDA Received Date: 01/31/2024
• Supplement Report FDA Received Date: 06/28/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/27/2019
• Is the Device Labeled for Single Use? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown