MAUDE Adverse Event Report: GETINGE IC PRODUCTION POLAND SP.Z O.O. 833 HC; 833HC

Device Problem Gas/Air Leak (2946)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 03/15/2019

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

On (b)(6) 2019 (b)(4) became aware of an issue with one of the devices manufactured by (b)(4)- 833 hc steam sterilizer.As it was stated, the steam leak occurred through door not fully closed.There was no injury reported, however it was decided to report the issue based on the potential as any unexpected steam leak from parts of the device available for the customer might lead to serious injury or worse.

Manufacturer Narrative

The issue is being investigated by manufacturing site.This report is being filed under exemption e2017051 by the manufacturer getinge ic production poland sp.Z.O.O, (b)(4) on behalf of the importer getinge group logistics america, llc, (b)(4).

Manufacturer Narrative

The issue is still being investigated by manufacturing site.This report is being filed under exemption e2017051 by the manufacturer getinge ic production poland sp.Z.O.O, (b)(4) on behalf of the importer getinge group logistics america, llc, (b)(4).

Manufacturer Narrative

On 6th april, 2019 getinge became aware of an issue with one of our devices - 833 hc steam sterilizer.As it was stated, the door on the loading side did not automatically close properly allowing a large amount of steam to escape into the room.When reviewing reportable events, we were able to establish that there is no apparent trend for complaints of this type.The product involved in the incident is the 833 steam sterilizer with the serial number (b)(6) the unit was manufactured on 22nd may, 2013 and installed on (b)(6) 2014.It was established that the device preventive maintenance (pm) was performed by customer maintenance staff who were trained by getinge representative on 4-5 november, 2014 and 25-26 july, 2018.The last annual pm was performed in september, 2018, including checking door mechanism.After the issue occurred, the device was inspected by customer's technician.It was noticed that the bolts on one of the door hangers had come loose which caused the door to be out of alignment and consequently allowing the steam to escape.As a remediate action the door was re-aligned by the customer technician.The getinge 833hc investigated herein feature fully automated power doors which are operated by the operator from the control panel.The door is suspended from 2 stainless steel blocks, which are each secured by 2 ½ inch stainless steel bolts, threaded into the door and tightened with lock washers.It was stated that from normal operation, these bolts had loosened over time allowing the rh block to move, which was apparent by a gap showing between the block and the door plate.The door closed switch, which is located on the lowest locking pin, ensures that the door plate is in proper position, prior to energizing the steam to gasket solenoid valve.In this case, the loose blocks had allowed the door plate to move away from the head ring, even though the switch was made.This event partially exposed the gasket and head ring, and allowed the cycle to start and steam to be expelled.The issue was investigated by manufacturing site.It was established that preventive maintenance performed by trained customer technicians was done on the device one time per year although manufacturer recommends performing actions quarterly.Moreover, it was established that customer technicians did not follow the manufacturer's instruction while performing pm on the device involved.To sum up, the possible root cause of the issue was established as the improper preventive maintenance performed by the customer technicians regarding time and procedure.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 accessory was not being used for patient treatment.Given the findings of this investigation getinge shall continue to monitor for any further events of this nature and does not propose any other action at this time.

• Brand Name: 833 HC
• Type of Device: 833HC
• Manufacturer (Section D): GETINGE IC PRODUCTION POLAND SP.Z O.O.; ul. szkolna 30; plewiska, plewiska 62064 ; PL 62064
• MDR Report Key: 8508240
• MDR Text Key: 141749769
• Report Number: 3012068831-2019-00001
• 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
• Remedial Action: Repair
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 07/02/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/12/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: No
• Event Location: Hospital
• Date Manufacturer Received: 04/06/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1