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

Model Number 8668

Device Problem Device Fell (4014)

Patient Problem Pain (1994)

Event Date 04/12/2024

Event Type  malfunction  

Event Description

On april 12, 2024 getinge became aware of an issue related to the 86-series washer disinfector, with the model name 8668.It was alleged that the rack fell.The getinge service technician visited the site and was informed that the employee was injured when a cart fell off a trolley and the employee tried to catch the rack.This resulted in the manager stating she hurt her shoulder.Upon investigating, all wash carts in service had proper hardware.The only noted missing hardware was on a new cart, which was missing a wheel.The trolley was placed out of service until the parts arrive.The injured manger was out sick the next day.No medical intervention was reported.There was no serious injury 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 a serious injury if the situation was to reoccur.

Manufacturer Narrative

Additional information will be provided following the conclusion of the investigation.

• Brand Name: 86-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: tina evancho ; ljungadalsgatan 11; vaxjo
• MDR Report Key: 19123424
• MDR Text Key: 340339987
• Report Number: 9616031-2024-00017
• Device Sequence Number: 1
• Product Code: MEC
• UDI-Device Identifier: 07340153700277
• UDI-Public: (01)07340153700277
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: User Facility,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 04/17/2024

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?: Yes
• Device Operator: Other
• Device Model Number: 8668
• Device Catalogue Number: S-86682003-CTOM
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: 04/12/2024
• Initial Date FDA Received: 04/17/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/10/2020
• Is the Device Single Use?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Outcome(s): Other