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

Model Number GETINGE RETURN CONVEYOR (RC 2.0)

Device Problem Mechanical Jam (2983)

Patient Problem Injury (2348)

Event Date 07/22/2020

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

On 22nd july, 2020 getinge became aware about an incident where rack got stuck while placed on return conveyor (rc), an accessory used with one of the medical devices, washer disinfector, from 8666 series.According to the information provided, when the rack got stuck the operator did not use the emergency button and attempted to fix the problem.At this point, when he approached the rc, the rack¿s arm popped out and hit the operator¿s hand.The incident resulted in a hand¿s cut.The return conveyor is not registered as a medical device, however it was being used with washer disinfector from 8666 series as a system, therefore will be reported such as.

Event Description

Manufacturer reference number: (b)(4).

Manufacturer Narrative

The issue is being investigated by manufacturing site.

Event Description

Manufacturer reference number (b)(6).

Manufacturer Narrative

Getinge became aware about an incident where a rack got stuck while placed on return conveyor (rc), an accessory used with one of the medical devices, washer disinfector, from 8666 series in facility.According to the information provided, the cause of the jam was a dislodged instrument or tray.Upon the device functionality interruption, the operator tried to fix the problem but did not activated the emergency stop prior to this activity.Once the rc was approached, the rack¿s arm popped out and hit the operator¿s hand.The device involved was recognized as ags return conveyor, manufactured in 2005 and installed in facility in 2007.The company representative, who visited the site after the incident occurrence, evaluated the involved device and was not able to find any technical malfunction.During the review performed we were able to find several customer product complaints, reported in the past, and were related to operator sustaining injury while operating the device automatic loading equipment.At the time when the event occurred, the getinge device was directly involved.It likely did met its specification, as device was operating properly when the technician arrived after customer allegation.Upon the event occurrence the device was not being used for patient treatment.Upon performed investigation, we were able to establish that the reported incident resulted from user not following instruction given in user manual, regarding both, correct rack loading and using of the emergency stop prior to any manual intervention within the device.Given the findings of this investigation getinge shall continue to monitor for any further events of this nature.

• Brand Name: AUTOMATION LOADING SYSTEM
• Type of Device: DISINFECTOR, MEDICAL DEVICES
• Manufacturer (Section D): GETINGE DISINFECTION AB; ljungadalsgatan 11; vaxjo
• MDR Report Key: 10350510
• MDR Text Key: 202225994
• Report Number: 9616031-2020-00028
• 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,Followup
• Report Date: 10/15/2020

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: Health Professional
• Device Model Number: GETINGE RETURN CONVEYOR (RC 2.0)
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: 07/22/2020
• Initial Date FDA Received: 07/31/2020
• Supplement Dates Manufacturer Received: 08/14/2020; 10/15/2020
• Supplement Dates FDA Received: 09/08/2020; 10/15/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other