MAUDE Adverse Event Report: GETINGE IC PRODUCTION POLAND SP. Z O.O. 400-SERIES; STERILIZER, STEAM

Model Number 433HC

Device Problems Leak/Splash (1354); Difficult to Open or Close (2921)

Patient Problems Burn(s) (1757); No Consequences Or Impact To Patient (2199)

Event Date 06/06/2019

Event Type  malfunction  

Manufacturer Narrative

The issue is being investigated by the manufacturin site.Device not returned to manufacturer.

Event Description

On (b)(6) 2019 getinge became aware of an issue with 433hc sterilizer.As it was stated, during start of the machine the door was not fully closed and this allowed steam coming out.In consequences, the operator burnt an arm.Based on the information provided, the sustained injury was not classified as serious one however, we decided to report the issue based on the potential for serious injury or worse, if the situation was to reoccur.

Manufacturer Narrative

Getinge became informed of an issue with a steam sterilizer 433hc device with serial number (b)(6).As it was stated, during start of the machine, the door was not fully closed and this allowed steam coming out.In consequences, the steam affected the techs hand with minor heat.There was no serious injury reported, however it was decided to report this issue based in the abundance of caution.When reviewing reportable events for this type of issues we were able to find one similar complaint.Fortunately, the event has not led to serious injury or worse.Preventive maintenance was being performed under getinge agreement at the time when the event occurred.When the event occurred, the device did not meet its specification and it contributed to event due to the door was not fully closed before the operator started the unit.The provided information did not indicate that the device was being used for patient treatment when the event took place.Based on performed root cause analysis we conclude that event is related to the door up limit switch was not adjusted properly or sticking.Nevertheless, if user would follow the user manual which contains information about using personal protective equipment when using the sterilizer, the minor heat which affected operator arms would not led to any injury.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).

Manufacturer Narrative

Additional information is provided to previous emdr follow up report #1 due to investigation update.Getinge has contacted the service representative that was responsible for the complaint and confirmed that no actual harm happened.The service representative also confirmed that limit switch was replaced and since the repair there are no problems with the door sealing on the sterilizer.The function of the door up limit switch is to confirm if the door is closed.The malposition or malfunction of this switch led to door being not fully closed, while it was indicating that the door was closed, and this in turn allowed the operator to start the process, while it should not have.Potential risk has been considered as low due to temperature of steam in hand location during pressing the start button is too low to cause operator¿s injury.Temperatures values has been confirmed by tests.History of complaints shows that occurrence of the event with a similar allegation is rare.The purpose of this submission is also to provide a correction of: adverse event or product problem; catalog #; event problem and evaluation codes (patient codes; conclusions).This is based on the result of updated investigation due to additional information.#b1 previous adverse event of product problem: marked "adverse event" and "product problem" corrected adverse event of product problem: marked "product problem" #b2 previous outcomes attributed to adverse event: marked "other serious (important medical events)" corrected outcomes attributed to adverse event: blank.#d4 previous catalog #: 4ssvuplra4ba.Corrected catalog #: 41svuphraaaa.#h6 previous patient code: 1757; conclusions: 19.Corrected patient code: 2199; conclusion: 19 and 4307.

Event Description

Manufacturer reference number: (b)(4).

• Brand Name: 400-SERIES
• Type of Device: STERILIZER, STEAM
• Manufacturer (Section D): GETINGE IC PRODUCTION POLAND SP. Z O.O.; szkolna 30; plewiska wielkopolskie
• MDR Report Key: 9823726
• MDR Text Key: 200818085
• Report Number: 3012068831-2020-00004
• Device Sequence Number: 1
• Product Code: FLE
• 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,Followup
• Report Date: 08/12/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 433HC
• Device Catalogue Number: 41SVUPHRAAAA
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: 06/07/2019
• Initial Date FDA Received: 03/12/2020
• Supplement Dates Manufacturer Received: 05/11/2020; 07/14/2020
• Supplement Dates FDA Received: 05/20/2020; 08/12/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other