MAUDE Adverse Event Report: GETINGE IC PRODUCTION POLAND SP. Z O.O. 800-SERIES; STERILIZER, STEAM

Model Number 833HC

Device Problems Leak/Splash (1354); Noise, Audible (3273)

Patient Problem Unspecified Ear or Labyrinth Problem (4474)

Event Date 04/16/2021

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 the following situation that took place with the 833hc sterilizer: the door gasket has blown out of the doors top corner during the cycle, which led to steam release (mostly water vapor) and noise creation.Due to this situation the customer alleged about hospital staff members that suffered hearing damage.The affected persons are claimed to be under the care of physician from occupational health.With the information received to date we are not aware about any specific medical treatment that had to be applied in relation to alleged outcome, therefore it was not classified as a serious injury.According to received information the latest repair of the device involved was done by a 3rd party.After the described incident took place the customer asked getting technician to confirm that unit is functioning properly.Getting service technician had made few adjustments such as door alignment, gap adjustment, pins adjustment and replaced the door gasket.Afterwards, the unit was concluded as fully operational and returned to the usage.We decided to report this case based on potential for serious injury if the above described situation was to reoccur, as a blown out gasket during the cycle may lead to an adverse consequences.

Manufacturer Narrative

Getinge became aware of the following situation that took place with the 833hc sterilizer: the door gasket has blown out of the door¿s top corner during the cycle, which led to steam release (mostly water vapor) and noise creation.Due to this situation the customer alleged about hospital staff members that suffered hearing damage.The affected persons were claimed to be under the care of physician from occupational health.With the information received to date we are not aware about any specific medical treatment that had to be applied in relation to alleged outcome, therefore it was not classified as a serious injury.We decided to report this case based on potential for serious injury if the above described situation was to reoccur, as a blown out gasket during the cycle may lead to an adverse consequences.Unit was addressed, concluded as fully operational and returned to the usage after the event.As a result of our investigation, we conclude that the getinge device did not meet its specification since the getinge technician needed to adjust the device and replace the seal.Steam leak during the cycle from door area contributed to the event.The device was not being used for patient treatment at the time when the event occurred.Based on the performed root cause analysis and input from subject matter expert and getinge technician which visited the customer we conclude that most probable root cause of event is that maintenance was not performed correctly by a third party technician.This caused door misalignment, increased door to headring gap resulted in partial gasket release which led steam leak and sound creation.Preventive maintenance is not being performed under getinge agreement on this device.When reviewing reportable events for this type of issues we were able to establish that the received incident is the sixth registered in getinge complaint handling systems of its kind.Fortunately, the event has not led to serious injury or worse with the information we have received to date.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 two answers in section f related to questions "report sent to fda?" and "report sent to manufacturer?".#f11: previous answer: yes.Corrected answer: - #f13: previous answer: yes corrected answer: -.

Event Description

Manufacturer reference number (b)(4).

• Brand Name: 800-SERIES
• Type of Device: STERILIZER, STEAM
• Manufacturer (Section D): GETINGE IC PRODUCTION POLAND SP. Z O.O.; szkolna 30; plewiska wielkopolskie
• MDR Report Key: 11745367
• MDR Text Key: 257207165
• Report Number: 3012068831-2021-00001
• 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,user f
• Type of Report: Initial,Followup
• Report Date: 07/28/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/29/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Model Number: 833HC
• Device Catalogue Number: UNKNOWN
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: Yes
• Date Manufacturer Received: 07/16/2021
• Patient Sequence Number: 1
• Patient Outcome(s): Other