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

Model Number	9128E
Medical Device Problem Code	Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/21/2022
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 21st november, 2022 getinge became aware of an issues related to manual trolley.The manual trolley is not registered as a medical device, however upon the situation occurrence it was used with the medical device washer disinfector with the model name 9128e.As it was stated, the loading trolley almost fell on the floor due to a faulty stop pin that is installed on the manual trolley to prevents the loading trolleys from falling off.The malfunctioned part was replaced and the manual trolley was returned to the service in full working condition.There was no injury or damage reported, however we decided to report the issue based on a potential as loading trolley falling to the floor could bring a hazardous situation for the operator and lead to serious injury if the situation was to reoccur.
Event or Problem Description
Manufacturer's reference number: (b)(4).
Additional Manufacturer Narrative
On (b)(6) 2022 getinge became aware of an issue related to smart trolley.The product involved in the customer product complaint is the 91e-series washer disinfector with model name 9128e and serial number (b)(6).The unit was manufactured on (b)(6) 2020 and installed on (b)(6) 2020.Upon the situation occurrence the smart trolley has been used with washer disinfector.As it was stated, the loading trolley almost fell on the floor due to a faulty stop pin that is installed on the manual trolley to prevents the loading trolleys from falling off.The malfunctioned part was replaced and the manual trolley was returned to the service in full working condition.The manufacturer required a more detailed description of the problem to determine its exact root cause, but unfortunately such information was not available.Trend review of customer product complaints with the same issue involved on 91-series, 90-series and 91e-series devices reported within the last 5 years was performed but did not provide any signals that triggered further scrutiny.When the incident occurred, the washer disinfector was not directly involved and it meet its specification.The alleged issue was related with device, which was used with washer disinfector ¿ smart trolley, which was directly involved and it not meet its specification.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 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.

• 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: 15894321
• Report Number: 9616031-2022-00028
• Device Sequence Number: 12437008
• Product Code: MEC
• UDI-Device Identifier: 07340153710061
• UDI-Public: (01)07340153710061
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• 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): 12/01/2022

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: 9128E
• Device Catalogue Number: 9128E-001
• 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: 11/21/2022
• Supplement Date Received by Manufacturer: 05/27/2024
• Initial Report FDA Received Date: 12/01/2022
• Supplement Report FDA Received Date: 05/29/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 04/28/2020
• Is the Device Labeled for Single Use? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown