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

Model Number	MST-H
Medical Device Problem Code	Problem with Software Installation (3013)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/10/2022
Type of Reportable Event	Malfunction
Event or Problem Description
During installation of a sterilizer, a gravity cycle was relabeled as prevacuum and the program parameters were changed accordingly, but the changed parameters were not saved.After shutdown of the system the parameters reverted to the original gravity cycle parameters while maintaining the prevacuum label.Inadvertently the incorrectly labeled cycle was run three times over the following two months before being detected and corrected.
Additional Manufacturer Narrative
Company investigation revealed that the service technician did not save the parameters for the changed program, but only the program name.The changed parameters were saved in the ram memory only.After the next shutdown and reboot of the system, the parameters were set back to the previous saved ones.There have been no issues with the outcome of the sterilization cycle that was run three times with incorrect parameters.The indicators that were placed in the sterilizer together with the sterile goods showed only good results.There are no known incidents with patient involvement due to the event.The program settings have been corrected to match the program name, as originally intended.The system was shut down and it was confirmed that the newly set parameters were correctly saved.Currently, the program is running correctly.

• Brand Name: MST-H-9-6-18 GR
• 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: 16388197
• Report Number: 3001061128-2023-00001
• Device Sequence Number: 20118379
• Product Code: FLE
• UDI-Device Identifier: 07640141626146
• UDI-Public: (01)07640141626146(11)220115
• 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
• Remedial Action: Repair
• Type of Report: Initial
• Report Date (Section B): 02/16/2023

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 Model Number: MST-H
• Device Lot Number: 2013590
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/17/2023
• Initial Report FDA Received Date: 02/16/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/15/2022
• 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