MAUDE Adverse Event Report: GETINGE IC PRODUCTION POLAND SP. Z.O.O 500-SERIES; 533HC

Model Number 533HC

Device Problem Leak/Splash (1354)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 08/14/2018

Event Type  malfunction  

Manufacturer Narrative

(b)(4).The issue is being investigated by manufacturer site.

Event Description

On (b)(6) 2018 we were informed about the incident with one of steam sterilizers 533hc.As it was stated by user, the steam has hit him in the face when he opened the door of it.There is no injury reported however we decided to report the issue in abundance of caution as it could led to an injury.

Manufacturer Narrative

This report is being filed under exemption e2017051 (b)(4).When reviewing similar reportable events for 500-series health care steam sterilizers we have been able to define that this is a second complaint received on unexpected, hot steam leak from the device towards the user.However the first such complaint with this outcome was caused by a different issue.There is no trend observed for this failure mode - it is the only complaint of its kind at this time.It was established that when the event occurred, the device did not meet its specification and it contributed to event, yet it was not used for the patient treatment or diagnosis.The device involved in the event is 500-series health care steam sterilizer with serial number (b)(4) and model number 533hc.Manufacturing date of the device is august 29th, 2009.The installation date of the device is april 9th, 2010, which gives us information that device was in use for over 8 years before the event occurred.Based on the performed evaluation we can conclude that an alarm condition occurred as the water was backed up into the chamber due to faulty drain check valve.That caused a pressure and stem buildup in the chamber, resulting in unexpected steam leak upon opening the door.Later on, when the company's representative evaluated the device, a screw was found in the drain check valve what caused the situation to occur.The screw was defined as chamber drain screen retention screw and the conclusion is that it must have been dropped into the drain when someone removed the screen for cleaning, before the situation investigated herein occurred.Operator manual (61301606090, rev.B) for 400/500 hc steam sterilizers which was current at the time when the affected device was manufactured includes proper warnings.Based on the information given the user shall not open the door until the alarm" water in drain" clears as it may cause hot water or steam evacuation.We believe that all remaining devices are performing correctly in the market.We also believe that if the manufacturer recommendation would have been followed the incident could have been avoided.The customer has been retrained in regards to safety usage of the device.We shall continue to monitor for any further events of this nature and do not propose any further action at this time.

Manufacturer Narrative

This report is being filed under exemption e2017051 (b)(4).The issue is still being investigated by manufacturer site.

Event Description

(b)(4).

• Brand Name: 500-SERIES
• Type of Device: 533HC
• Manufacturer (Section D): GETINGE IC PRODUCTION POLAND SP. Z.O.O; szkolna 30; plewiska, 62-06 4; PL 62-064
• Manufacturer (Section G): GETINGE IC PRODUCTION POLAND SP. Z.O.O.; szkolna 30; plewiska, 62-06 4; PL 62-064
• Manufacturer Contact: dennis genito ; 45 barbour pond drive; wayne, NJ 07470 ; 9737097515
• MDR Report Key: 7855203
• MDR Text Key: 119653737
• Report Number: 3012068831-2018-00010
• Device Sequence Number: 1
• Product Code: FLE
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,user f
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 10/03/2018,10/29/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/07/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: 533HC
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 10/03/2018
• Event Location: Hospital
• Date Manufacturer Received: 09/07/2018
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 08/29/2009
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1