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

Model Number 9128E

Device Problems Adverse Event Without Identified Device or Use Problem (2993); Device Handling Problem (3265)

Patient Problem Muscle/Tendon Damage (4532)

Event Date 12/23/2021

Event Type  malfunction  

Event Description

On 2nd march, 2022 getinge received the information about the event which was related to the manual trolley universal wash cart 2000 used with the 91e-series washer disinfector.As it was stated on (b)(6) 2021 an operator reported a strain injury while towing the trolley in the washing tunnel.The operator reported that the wheels were stuck in the grooves.After the medical examination the operator was 7 days off work to recover from the injury.Based on the available information we cannot classify the health impact, however we decided to report the issue in abundance of caution and based on the potential as we cannot confirm that similar events could not contributed to the serious injury if reoccur.

Manufacturer Narrative

Additional information will be provided following the conclusion of the investigation.Device not returned to the manufacturer.

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.

Event Description

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

• 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: 13820049
• MDR Text Key: 296225102
• Report Number: 9616031-2022-00006
• 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,Followup
• Report Date: 03/18/2022

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: 9128E-001
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: 03/02/2022
• Initial Date FDA Received: 03/19/2022
• Supplement Dates Manufacturer Received: 03/14/2022
• Supplement Dates FDA Received: 12/14/2023
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 10/07/2020
• Is the Device Single Use?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Outcome(s): Other