MAUDE Adverse Event Report: BELIMED AG MST-H-9-6-18 HS2; STERILIZER

Lot Number	2015900
Medical Device Problem Codes	Mechanical Problem (1384); Improper or Incorrect Procedure or Method (2017)
Health Effect - Clinical Code	Burn(s) (1757)
Date of Event	07/12/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Investigation of the incident is in progress.A follow-up report will be submitted when additional information becomes available.
Event or Problem Description
The sterilizer, equipped with a ground-loading system and designed for automatic loading and unloading, experienced a malfunction during the unloading process.During the incident, the unloading function executed only partially, leaving the second cart inside the unit.The spd technician attempted to manually remove the second cart using a metal rod.In the process she backed up into a hot rack that had been left there to cool down, resulting in burns with blistering and peeling on her arm.Medical care was provided by employee health services and the technician was able to return to work.
Additional Manufacturer Narrative
Testing performed on site at the healthcare facility found that the sterilizer's unloading automation was fully functional, operating as designed.However, it was observed that the cspd staff was loading the batch carts manually, potentially affecting the racks' position inside the chamber and thus preventing successful unloading.The cspd manager was informed of the situation, stressing the importance of using the loading automation for proper rack positioning inside the chamber.The following fields were modified in this supplement report> b1, b4, g3, g6, h2, h6, h11.

• Brand Name: MST-H-9-6-18 HS2
• Common Device Name: STERILIZER
• Manufacturer (Section D): BELIMED AG; grienbachstrasse 11; zug, zug 6300 ; SZ 6300
• Manufacturer (Section G): BELIMED AG; grienbachstrasse 11; zug, zug 6300 ; SZ 6300
• Manufacturer Contact: heidi friesacher ; grienbachstrasse 11; zug, zug 6300 ; SZ 6300
• MDR Report Key: 20004371
• Report Number: 3001061128-2024-00001
• Device Sequence Number: 7433435
• Product Code: FLE
• UDI-Device Identifier: 07640141626146
• UDI-Public: (01)07640141626146(11)220624
• Combination Product (Y/N): N
• Initial Reporter State: SC
• Initial Reporter Country: US
• PMA/510(K) Number: K191896
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Distributor
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 09/11/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Other
• Device Lot Number: 2015900
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/19/2024
• Supplement Date Received by Manufacturer: 09/05/2024
• Initial Report FDA Received Date: 08/20/2024
• Supplement Report FDA Received Date: 09/11/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/11/2022
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown