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

Model Number 9128

Device Problem Leak/Splash (1354)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 08/16/2019

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

On 16th august, 2019 getinge became aware of an issue with one of washer disinfector - 9128.As it was stated, a condensate leak caused sprinkler head to engage.There was no injury reported however we decided to report the issue in abundance of caution as any unexpected, excessive leak from parts available for the operator might cause adverse consequences.

Manufacturer Narrative

On 16th august, 2019 getinge became aware about an issue with one of the washer disinfector: 9128.The unit was installed in 2008.When reviewing reportable events for this type of issues we were able to establish that received incident is one in a series of complaints over the past 5 years, with this device series, for issues where unexpected steam leak from device locations facing the customer occurred.All of them were decided to be reportable to competent authorities based on the potential, in none a serious injury or worse occurred.The information collected to date and as a result of the performed investigation allowed us to establish that fire alarm was triggered due to the steam leaking through the devices¿ door.The door was unlocked after the unit displayed the error code (which is safety activity of device ensuring the correct parameters of cleaning).Additionally, the device manual is instructing the operator which actions should be performed to correct the situation and those do not require an opening of the door.In summary, the most likely root cause for the event appears to be related to activities performed by customer which were not in line with steps given as part of the instruction of service manual.When the alarm occurred, the qualified personnel should follow the instruction which does not require opening of the door, thus even if the steam is cumulated in the chamber, there would be no chance for the external leak and the fire alarm activation.When the event occurred, the device did not meet its specification and it contributed to event.Upon the event occurrence the device was not being used for patient treatment.We currently do not have any information that would warrant further action towards the device manufacturing or devices on the market, however getinge will continue to monitor the customer experiences with the device for any future information.

Event Description

Manufacturer reference number (b)(4).

• Brand Name: 91-SERIES
• Type of Device: DISINFECTOR, MEDICAL DEVICES
• Manufacturer (Section D): GETINGE DISINFECTION AB; ljungadalsgatan 11; vaxjo
• MDR Report Key: 9424636
• MDR Text Key: 200049168
• Report Number: 9616031-2019-00038
• 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: 03/05/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 9128
• Device Catalogue Number: UNKNOWN
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 08/16/2019
• Initial Date FDA Received: 12/06/2019
• Supplement Dates Manufacturer Received: 02/19/2020
• Supplement Dates FDA Received: 03/05/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1