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

Model Number GSS67H

Device Problems Improper or Incorrect Procedure or Method (2017); Adverse Event Without Identified Device or Use Problem (2993); No Apparent Adverse Event (3189)

Patient Problem Burn(s) (1757)

Event Date 09/09/2021

Event Type  malfunction  

Manufacturer Narrative

Additional information will be provided following the conclusion of the investigation.Device not returned to manufacturing site.

Event Description

On (b)(6) 2021 getinge became aware of an issue with gss67h steam sterilizer.As it was stated, during the repair of device which had problem with vacuum timeout alarm, service technician burned his hand on an uninsulated steam pipe to the jacket on the machine.The sustained burn did not require a medical intervention, thus was not classified as a serious one.We decided to report the issue based on the potential as it could lead to serious injury or worse and based on the similarity of models between gss67h and gss67n.

Event Description

Manufacturer reference number (b)(4).

Manufacturer Narrative

Getinge became aware of an issue with gss67h steam sterilizer.As it was stated, during the repair of device which had problem with vacuum timeout alarm, service technician burned his hand on an uninsulated steam pipe to the jacket on the machine.The sustained burn did not require a medical intervention, thus was not classified as a serious one.However it was decided to report the issue based on the potential as the scenario described could lead to serious injury or worse and based on the similarity of models between gss67h and gss67n.Service was completed and device was returned to usage.With the information received, we conclude that the getinge device did meet its specification but it contributed to the event.The device was not being used for patient treatment at the time when the event occurred.When reviewing reportable events for this type of issues we were able to establish that the received incident is the first one registered in getinge complaint handling systems.Fortunately, the event has not led to serious injury or worse.The case was analyzed by the subject matter expert.It was concluded that there is a technical/process related reason for not having this pipe insulated and that the technician in question is certified on the gss67 and in that case should be aware of the hazards connected to servicing the unit.Based on our analysis, getinge established the most likely root cause to be related to the service.Warnings about hazards, possible in the service area, are included in the service manual and certified technicians shall be aware of it.We currently do not have any information that would warrant further action towards the devices, however as per our complaint handling processes will continue to monitor the customer experiences with the device for any future information.The purpose of this submission is also to provide a correction of field #h6 medical device - problem code.This is based on the result of an internal review.Previous #h6 medical device - problem code: 3189.Corrected #h6 medical device - problem code: 2993 and 2017.

• Brand Name: GSS67
• Type of Device: STERILIZER, STEAM
• Manufacturer (Section D): MAQUET GMBH; kehler strasse 31; rastatt ; GM
• Manufacturer (Section G): MAQUET GMBH; kehler strasse 31; rastatt ; GM
• Manufacturer Contact: dennis genito ; kehler strasse 31; rastatt ; GM
• MDR Report Key: 12598213
• MDR Text Key: 275421242
• Report Number: 8010652-2021-00028
• Device Sequence Number: 1
• Product Code: FLE
• Combination Product (y/n): N
• Reporter Country Code: DA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,User Facility,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 11/05/2021

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?: No
• Device Operator: Other
• Device Model Number: GSS67H
• Device Catalogue Number: GSS67H
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 09/09/2021
• Initial Date FDA Received: 10/08/2021
• Supplement Dates Manufacturer Received: 10/28/2021
• Supplement Dates FDA Received: 11/07/2021
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 06/19/2018
• Is the Device Single Use?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Outcome(s): Other