MAUDE Adverse Event Report: GETINGE IC PRODUCTION POLAND SP. Z O.O. 700-SERIES; STERILIZER, STEAM

Model Number 733HC-E

Device Problems Device Dislodged or Dislocated (2923); Device Handling Problem (3265)

Patient Problem Burn(s) (1757)

Event Date 02/27/2020

Event Type  malfunction  

Manufacturer Narrative

Issue is being investigated by the manufacturing site.

Event Description

On 27th february, 2020 getinge became aware of an issue with 733hc-e sterilizer.As it was stated, the operator burn forearm during loading the cart into sterilizer which wheels were hanging off the chamber rail.There was no information provided if employees needed medical intervention however, we decided to report the issue based on the potential as such situation may lead to serious injury or worse.

Manufacturer Narrative

Getinge became informed of an issue with a steam sterilizer 733hc-e device with serial number (b)(6).As it was stated, the operator scalded their forearm during the loading of the loading cart, into the sterilizer.There wasn't any serious injury reported due to this case however, we decided to report the issue based on the potential for serious injury.When reviewing reportable events for this type of issues we were able to find several similar complaints where the trolley has not been locked to the sterilizer and the cart fell down from the rail.The device was manufactured on 7th august, 2019 and installed on 21th september, 2019.The history for the device was reviewed and no related anomalies were found.The device was released to the customer in a fully working condition.When the event occurred, the device did meet its specification and it passively contributed to the event.The provided information did not indicate that the device was being used for patient treatment when the event took place.Based on performed root cause analysis we conclude that the adverse event is related to the trolley not being properly docked and locked to the sterilizer and that this in turn is caused by user error.The customer was informed and the relevant staff were indicated to have been retrained.We currently do not have any information that would warrant further action towards the device manufacturing or devices on the market, however as per our complaint handling processes will continue to monitor the customer experiences with the device for any future information.

Event Description

Manufacturer reference number ot: (b)(4).

• Brand Name: 700-SERIES
• Type of Device: STERILIZER, STEAM
• Manufacturer (Section D): GETINGE IC PRODUCTION POLAND SP. Z O.O.; szkolna 30; plewiska wielkopolskie
• MDR Report Key: 9785752
• MDR Text Key: 206756587
• Report Number: 3012068831-2020-00003
• 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: 05/18/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/04/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 733HC-E
• Device Catalogue Number: 7CRVUPHTTAAA
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 05/08/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other