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

Model Number	8668
Medical Device Problem Code	Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/01/2024
Type of Reportable Event	Malfunction
Event or Problem Description
On (b)(6) 2024 getinge became aware of an issue related to the 86-series washer disinfector, with the model name 8668.It was alleged that there were loading issues.The getinge service technician visited the site and found that cart had fallen of the loading trolley to the ground.It was caused by a mechanical failure on the loading trolley.The trolley was repaired and the unit was handed back to the customer in a fully working condition.There was no injury or damage reported, however we decided to report the issue based on a potential as carts falling off the trolley could bring a hazardous situation for the operator and lead to serious injury if the situation was to reoccur.
Additional Manufacturer Narrative
Additional information will be provided following the conclusion of the investigation.
Event or Problem Description
Manufacturer's reference number: (b)(4).
Additional Manufacturer Narrative
On march 1st, 2024 getinge became aware of an incident that happened on the loading trolley working with the 46- series washer disinfector, with the model's name 46-4 and serial number (b)(6).The washer disinfector was manufactured on april 21st, 2017.The reported issue is related to the cart fall on the washer disinfector model 8668 due to a mechanical failure on the loading trolley.This issue could potentially lead to serious injury; however, we have not received any signs of any health consequences related to found issue.Based on the investigation and information provided in the incident report, at the time of the incident the device wasn¿t working according to the specification.The trolley dockings were broken and thus not fit for use; the pin had been stuck on the unloader.This caused an issue with falling cart on washer disinfector 8668.According to service manual for getinge freestanding loading and unloading conveyor (6001392602_serv_fslc_fsuc_en_revg), the technician is responsible for checking pin in every preventive maintenance.The importance of reading the manual, understanding the machine and taking action in accordance with the instructions is crucial for achieving the correct function of the devices.There were a two system failures which indicates that the service might not have been done according to the service manual.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.When the incident occurred, the product was directly involved.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 devices 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: 18957584
• Report Number: 9616031-2024-00014
• Device Sequence Number: 18478223
• Product Code: MEC
• UDI-Device Identifier: 07340153700277
• UDI-Public: (01)07340153700277
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• 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): 03/22/2024

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: 8668
• 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: 03/01/2024
• Supplement Date Received by Manufacturer: 10/03/2024
• Initial Report FDA Received Date: 03/22/2024
• Supplement Report FDA Received Date: 10/03/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/21/2017
• Is the Device Labeled for Single Use? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown