MAUDE Adverse Event Report: MAQUET GMBH GSS67; STERILIZER, STEAM

Model Number GSS67H

Device Problems Labelling, Instructions for Use or Training Problem (1318); Pressure Problem (3012)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 02/18/2021

Event Type  malfunction  

Manufacturer Narrative

Additional information will be provided following the conclusion of the investigation.

Event Description

On (b)(6) 2021 getinge became aware of an issue with gss67h sterilizer.As it was stated, a sterilizer was installed as per the fitting instructions with eight bar steam supply to the machine.During the inspection is was discovered that the machine rating plate showed maximum pressure that allowed to be supplied as six bar.It was found that the issue is related to sterilizers with steam-to-steam converter option.With the received allegation, there was no adverse consequences due to mentioned steam supply connection however we decided to report the issue in abundance of caution as it may lead to hazardous situation.This same solution steam-to-steam converter is used in gss67n sterilizer.

Manufacturer Narrative

Getinge became aware of an issue with gss67h sterilizer.As it was stated, a sterilizer was installed as per the installation instructions with eight bar steam supply to the machine.During the inspection it was discovered that the machine rating plate showed maximum pressure that allowed to be supplied as six bar.It was found that the issue is related to sterilizers with steam-to-steam converter option.As for the initially received allegation, there have been no adverse consequences due to mentioned steam supply connection however we initially decided to report the issue in abundance of caution as we considered there was a potential that the situation might lead to hazardous situation.The getinge technician received the recommendation and the visit at customer will be planned to address the issue.When reviewing reportable events for this type of issues we were able to establish that the received incident is one of only six registered in getinge complaint handling systems for this specific failure mode.None have led to the outcome of serious injury or worse.During the investigation it has been established that the issue is not presenting any immediate hazardous situation for the user.The safety margins on components were re-calculated with the assistance of the kiwa inspecta ab design review dept.And considered higher than 8 bar, therefore the safety risk is insignificant.The strength calculation results fulfil the requirements in en 13445-3:2014 and en 13480-3:2017.When the event occurred, the device did not meet its specification due to too high pressure being supplied to the device, when comparing to the nameplate and it contributed to event.The provided information did not indicate that the device was being used for patient treatment when the event took place.Based on the performed investigation the cause of the issue was an undocumented change of data sheets defining the maximum pressure inlet to the pressure converter.In addition the disregard of the type plate - which states a maximum of 6 bar ¿ was also identified.

Event Description

Manufacturer reference number (b)(4).

• Brand Name: GSS67
• Type of Device: STERILIZER, STEAM
• Manufacturer (Section D): MAQUET GMBH; kehler strasse 31; rastatt
• MDR Report Key: 11385491
• MDR Text Key: 240330293
• Report Number: 8010652-2021-00007
• 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,foreig
• Type of Report: Initial,Followup
• Report Date: 04/27/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/26/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: GSS67H
• Device Catalogue Number: GSS67H
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: Yes
• Date Manufacturer Received: 04/15/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1