MAUDE Adverse Event Report: BELIMED AG BELIMED STEAM STERILIZER MST-H TOP 5000

Model Number GR 9-6-15 HS2

Device Problem Problem with Software Installation (3013)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 11/20/2018

Event Type  malfunction  

Manufacturer Narrative

Although the prevacuum cycle was initially mislabeled as gravity on (b)(6) 2018, a single run of the incorrectly labeled cycle was carried out on the same day for verification purposes and the error was detected.The name of the program was corrected on 11/22/2018, before the program was incorporated into routine use at the healthcare facility.It is running properly.

Event Description

On (b)(6) 2018, a prevacuum sterilization cycle was programmed on a sterilizer, but incorrectly labeled as a gravity cycle.

• Brand Name: BELIMED STEAM STERILIZER MST-H TOP 5000
• Type of Device: STEAM 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: 11712837
• MDR Text Key: 250272329
• Report Number: 3001061128-2021-00009
• Device Sequence Number: 1
• Product Code: FLE
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K170228
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 04/22/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/23/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Model Number: GR 9-6-15 HS2
• Device Lot Number: 24212
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 03/23/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/11/2015
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1