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

Model Number 9120E

Device Problems Leak/Splash (1354); Misassembled (1398)

Patient Problem No Patient Involvement (2645)

Event Type  malfunction  

Manufacturer Narrative

The issue is to be investigated.Device not returned to the manufacturer.

Event Description

On 5th february, 2020 getinge became aware of an issue with one of the washer-disinfectors - 9120e.As it was stated, safety line mechanism was activated by itself during the cycle.It caused the door to open and the steam to leak out of the unit.The hot steam activated the fire alarm.With the complaint at hand there was no injury reported, however it was decided to report this issue in abundance of caution as any unexpected steam leak from parts available for the customer might cause an injury.

Manufacturer Narrative

When reviewing reportable events for this type of issues we were able to establish that the received incident is the 4th one registered in the getinge complaint handling systems in last five years for the similar issue as the one investigated herein.In no previous case a serious injury or worse occurred and all were reported based on the potential.When the event occurred, the device was directly involved and did not meet its specification, contributing to event.Upon the event occurrence the device was not being used for patient treatment.During the investigation course, we were able to establish that the hot steam leaked from the door opened during the cycle.The door opened because of the safety line mechanism being triggered.The safety line mechanism was found to be maladjusted and was most likely activated during the process by a slight touch (e.G by movement of loading racks or even a water splash).The getinge technician, who visited the customer, repaired the device by adjusting the part.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: 91E-SERIES
• Type of Device: DISINFECTOR, MEDICAL DEVICES
• Manufacturer (Section D): GETINGE DISINFECTION AB; ljungadalsgatan 11; vaxjo
• MDR Report Key: 9774512
• MDR Text Key: 200050785
• Report Number: 9616031-2020-00009
• Device Sequence Number: 1
• Product Code: MEC
• UDI-Device Identifier: 07340153710023
• UDI-Public: (01)07340153710023
• 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: 06/18/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/02/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: 9120E
• Device Catalogue Number: UNKNOWN
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 06/10/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1