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

Model Number	9127E
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	03/10/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The issue is to be investigated by the manufacturing site.Device not returned to manufacturer.
Event or Problem Description
On 10th march, 2020 getinge became aware of an issue with one of washer-disinfectors: 9127e.As it was stated, after the drain cycle, when the door was opened, a hot condensate and steam was still in chamber and it leaked out, causing the fire alarm being turned off.There was no injury reported however we decided to report the issue in abundance of caution such situation could have an adverse consequences.
Additional Manufacturer Narrative
The issue is still being investigated.
Event or Problem Description
Manufacturer reference number (b)(4).
Event or Problem Description
Manufacturer reference number (b)(4).
Additional Manufacturer Narrative
Issue is still being investigated by manufacturing site.
Additional Manufacturer Narrative
When reviewing reportable events for 90-, 91- and 91e series of devices we were able to establish, that the issue investigated herein is the second reportable complaint for the issue regarding steam leak occurring after the complete drain cycle.Fortunately, none of those 2 complaints has resulted in serious injury or worse.The device involved in this event was a washer disinfectors ¿ 9127e.The unit was manufactured on 16th december, 2019 and installed on 1th march 2020.The information collected to date and as a result of the performed investigation allowed us to establish that devices¿ door was opened after the ¿complete drain¿ cycle.Then the hot vapor leaked through the opened door and activated the smoke detector.The ¿complete drain¿ cycle is to drain the water from device piping and booster tank.It is designated to be used by the customer to empty the tanks after unit was on standby for more than 48hours.The cycle is also intended to empty the device from water to perform the inspections or repairs.No drying or ventilation phase is provided after the ¿complete drain¿ cycle as is should be utilized with cold water.In the case at hand, the program most likely was run shortly after washing/disinfecting cycle.In such situation, the water on boosters could still be hot from previous activities (up to 90 celsius degrees) and then the vapor from draining water could fill the chamber and leak after opening the door.In summary, when the event occurred, the getinge device was directly involved.It did met its specification as the drying phase is not provided per devices¿ design and specification of this specific cycle.Upon the event occurrence the device was not being used for patient treatment.Given the circumstances and the fact that there was no actual device malfunction we do not propose any additional actions at this point.
Event or Problem Description
Manufacturer reference number (b)(4).

• Brand Name: 91E-SERIES
• Common Device Name: DISINFECTOR, MEDICAL DEVICES
• MDR Report Key: 9864559
• Report Number: 9616031-2020-00015
• Device Sequence Number: 560956
• Product Code: MEC
• UDI-Device Identifier: 07340153710054
• UDI-Public: (01)07340153710054
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 06/01/2020

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
• Operator of Device: No Information
• Device Model Number: 9127E
• Device Catalogue Number: UNKNOWN
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 03/10/2020
• Supplement Date Received by Manufacturer: 04/14/2020; 04/29/2020; 06/01/2020
• Initial Report FDA Received Date: 03/23/2020
• Supplement Report FDA Received Date: 05/08/2020; 05/22/2020; 06/01/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1