MAUDE Adverse Event Report: GETINGE DISINFECTION AB AUTOMATION LOADING SYSTEM; DISINFECTOR, MEDICAL DEVICES

Model Number GETINGE RETURN CONVEYOR (RC 2.0)

Device Problem Detachment of Device or Device Component (2907)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Type  malfunction  

Manufacturer Narrative

The issue is being investigated by the manufacturing site.Device not returned to the manufacturing site.

Event Description

On 10th december, 2019 getinge became aware of the problem with return conveyor, which is a loading/unloading system used with getinge medical devices.As it was stated, customer called the service, because two carts has fallen off the end of conveyor.There was no injury reported and no damage of property, nevertheless we decided to report the complaint based on the potential an in abundance of caution.

Manufacturer Narrative

When reviewing reportable events for this type of issues we were able to find several customer product complaints registered in the getinge complaint handling systems for issues where the carts and racks fell from the unloading systems due to various reasons.In one previous case a serious injury occurred, therefore we decided to report this complaint based on the risk potential.When the event occurred, the device did not meet its specification and it contributed to event.Upon the event occurrence the device was directly involved, however it was not being used for patient treatment.During the investigation course, we were able to establish that the rack fell down due to the transport rollers not stopping after the cart reached the end of the unloader.The rollers¿ faulty behavior was most likely caused by the misassembly of a magnet kit on the racks, causing the sensor not recognizing the cart position and not providing a feedback, slow and stop impulse, to the rollers motor.The issue occurred 6 months after the installation of the device.The most likely root cause was established as a faulty adjustment of the magnets during the installation of the device caused by the technician error.After the event, the magnets was adjusted, device was repaired and turned back to the customers¿ usage.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 reference number (b)(4).

• Brand Name: AUTOMATION LOADING SYSTEM
• Type of Device: DISINFECTOR, MEDICAL DEVICES
• Manufacturer (Section D): GETINGE DISINFECTION AB; ljungadalsgatan 11; vaxjo
• MDR Report Key: 9488292
• MDR Text Key: 200049725
• Report Number: 9616031-2019-00040
• Device Sequence Number: 1
• Product Code: MEC
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,user f
• Type of Report: Initial,Followup
• Report Date: 06/17/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/18/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: GETINGE RETURN CONVEYOR (RC 2.0)
• Device Catalogue Number: UNKNOWN
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 06/03/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1