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

Model Number 9125E

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

Patient Problem No Patient Involvement (2645)

Event Date 05/01/2020

Event Type  malfunction  

Manufacturer Narrative

Additional information will be provided upon results of investigation.Device not returned to manufacturer.

Event Description

On (b)(6) 2020 getinge became aware of an issue with one of the washer disinfector - 9127e device.As it was stated during the drying phase unit aborted and safety line tripped causing door to opened what resulted in vapor leak from the device and activation of sprinkler head.No person was at the place when the issue occured however we decided to report this case in abundance of caution and based on potential as an excessive vapor leak could led to serious injury.Manufacturer's reference number (b)(4).

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 for harm rather than having caused actual harm.When the event occurred, the device was directly involved and did not meet its specification, contributing to the event.Upon the event occurrence the device was not being used for patients¿ treatment.During the investigation course, we were able to establish that the hot vapor leaked from the door opened after the cycle was aborted.The door opened most likely because of the safety line mechanism being triggered.If the safety line mechanism is maladjusted, it can be activate 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 adjusted the part and return fully operational device to the usage.The most likely root cause of the part maladjustment was established as lack of maintenance on the device.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.Corrected data: there is also correction of the manufacturing date of the device included in 'manufacture date' section, as there were incorrect date provided in the initial complaint submission.This is based on the result of the review of documents provided by the manufacturer regarding the affected device.#h7: previous manufacture date: 12/04/2018.Corrected manufacture date: 11/30/2018.

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: 10086269
• MDR Text Key: 198755534
• Report Number: 9616031-2020-00019
• 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: 08/06/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/26/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 9125E
• Device Catalogue Number: 9125E-001
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 07/24/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1