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

Model Number 9128E

Device Problem Device Handling Problem (3265)

Patient Problem Bruise/Contusion (1754)

Event Date 01/10/2022

Event Type  malfunction  

Event Description

Manufacturer's reference number: (b)(4).

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 (b)(6) 2022 in the customer facility, operator bruised his foot during the activity of extracting the containers from the highest shelf.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.

• Brand Name: 91E-SERIES
• Type of Device: 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: 18325070
• MDR Text Key: 330586614
• Report Number: 9616031-2023-00030
• Device Sequence Number: 1
• Product Code: MEC
• UDI-Device Identifier: 07340153710061
• UDI-Public: (01)07340153710061
• Combination Product (y/n): N
• Reporter Country Code: IT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,User Facility,Company Representative
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 12/14/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/14/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Model Number: 9128E
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 03/14/2022
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 10/14/2020
• Is the Device Single Use?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Outcome(s): Other