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

Model Number	9128E
Medical Device Problem Code	Device Handling Problem (3265)
Health Effect - Clinical Code	Muscle/Tendon Damage (4532)
Date of Event	12/23/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
On 2nd march, 2022 getinge received an information about the event which was related to the 91e-series washer disinfector.The device involved in the incident was the universal wash cart 2000 trolley which cooperated with one of the three washer disinfectors.It was not possible to determine which exact washer disinfector was involved in this particular incident.On 23rd december, 2021 in the customer facility, the device operator experienced a muscle strain injury while pulling the trolley from the washing tunnel.The operator reported that the wheels had become "stuck" in the grooves.After the event the operator had a medical examination at the emergency room.The operator was given 7 days off work to recover from the injury.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.As a result of performed investigation we could establish that the most probable root cause of the event is related to a user error due to not following the manufacturer's recommendations contained in the user manual (doc.Id 6001855402 rev.J), which resulted in overloading the trolley.We report the event in abundance of caution and based on the potential for a serious injury if the situation was to reoccur.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.H3 other text : device not returned to the manufacturer.
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: dennis genito ; ljungadalsgatan 11; vaxjo
• MDR Report Key: 18325077
• Report Number: 9616031-2023-00027
• Device Sequence Number: 7391473
• Product Code: MEC
• UDI-Device Identifier: 07340153710061
• UDI-Public: (01)07340153710061
• Combination Product (Y/N): N
• Initial Reporter Country: IT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,User Facility,Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 12/14/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Model Number: 9128E
• Device Catalogue Number: UNKNOWN
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/14/2022
• Initial Report FDA Received Date: 12/14/2023
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 10/09/2020
• Is the Device Labeled for Single Use? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown