MAUDE Adverse Event Report: GETINGE IC PRODUCTION POLAND SP. Z O.O. 133HC; STERILIZER, STEAM

Model Number 133HC

Device Problem Leak/Splash (1354)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 07/23/2019

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

On 24th july, 2019 getinge became aware about an issue with one of the steam sterilizer- 133hc.As it was stated, the steam leaked out the door.The circumstances of the issue re unknown as well there was no injury reported.However, taking under consideration the worse case scenario it was decided to report the issue based on the potential as any unexpected steam leak from parts available for the customer might led to an adverse event.

Event Description

Manufacturer reference number: (b)(4).

Manufacturer Narrative

On 24th july, 2019 getinge became aware about an issue with one of the steam sterilizer- 133hc.As it was stated, the sterilizer alarmed and steam leaked out the door.Due to this, a loud sound was audible.When the issue occurred, no one was close to the device and no medical procedures were interrupted, however it was decided to report this issue based on the potential.After issue occurrence, the device was inspected by a getinge technician.It was stated that the door switch was out of adjustment and the door gasket was out of the gasket head ring.In addition, the door gasket valves were checked and found to be operational.The product involved in the incident is the 133hc steam sterilizer with the serial number: (b)(6).The unit was manufactured in 1999 and installed 2000.When reviewing reportable events, we were able to establish that with this device model, the issue is considered as a single and isolated event.Performed investigation allowed us to establish that due to the age of device involved, the door switch became loose and indicated ¿door closing¿ before the door reached the closed position.In addition, the door gasket became misplaced and created a gap in the device door,which most likely contributed to the steam release.In summary, when the event occurred, the device did not meet its specification and it contributed to the event.In the time when the event occurred, the device was not being used for patient treatment.After the issue occurrence, the door gasket was replaced, the door switch was adjusted and the device was returned for customer usage.Given the findings of this investigation and fact that customer is considering a replacement of the device for a newest one, getinge shall continue to monitor for any further events of this nature and does not propose any other action at this time.

• Brand Name: 133HC
• Type of Device: STERILIZER, STEAM
• Manufacturer (Section D): GETINGE IC PRODUCTION POLAND SP. Z O.O.; szkolna 30; plewiska wielkopolskie
• MDR Report Key: 8873669
• MDR Text Key: 216614106
• Report Number: 3012068831-2019-00008
• 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
• Remedial Action: Notification
• Type of Report: Initial,Followup
• Report Date: 09/04/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/08/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: 133HC
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 07/24/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1