MAUDE Adverse Event Report: GETINGE DISINFECTION AB 46-SERIES; DISINFECTOR, MEDICAL DEVICES

Model Number 46-4

Device Problem Failure to Clean Adequately (4048)

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

Event Date 03/21/2024

Event Type  malfunction  

Manufacturer Narrative

Additional information will be provided following the conclusion of the investigation.

Event Description

On march 21, 2024 getinge became aware of an issue with the 46-series washer disinfector.As it was stated the machine was leaking water.The getinge service technician visited customer site on (b)(6) 2024 and inspected the device.No leakage was found, however the issue with the detergents was noticed - incorrect detergent was plugged to the device.This problem can lead to insufficient cleaning process of the instruments.The issue was not detected by the user and it was not confirmed that the instruments were reprocessed before used on patients.So far, we have not been informed about any serious injury as a consequence of reported issue, however we decided to report the issue in abundance of caution and based on the potential for a serious injury if the situation was to reoccur as mixed detergents during process may lead to use of incorrectly cleaned instruments on patients.

• Brand Name: 46-SERIES
• Type of Device: DISINFECTOR, MEDICAL DEVICES
• Manufacturer (Section D): GETINGE DISINFECTION AB; ljungadalsgatan 11; vaxjo
• Manufacturer (Section G): GETINGE DISINFECTION AB; ljungadalsgatan 11; vaxjo
• Manufacturer Contact: tina evancho ; ljungadalsgatan 11; vaxjo
• MDR Report Key: 19094760
• MDR Text Key: 339984326
• Report Number: 9616031-2024-00016
• Device Sequence Number: 1
• Product Code: MEC
• UDI-Device Identifier: 07340153710368
• UDI-Public: (01)07340153710368
• Combination Product (y/n): N
• Reporter Country Code: SW
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,User Facility,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 04/12/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/12/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Model Number: 46-4
• Device Catalogue Number: 46-4-402-CTOM
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 03/28/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/30/2022
• Is the Device Single Use?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1