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

Model Number 46-5T

Device Problem Unintended Electrical Shock (4018)

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

Event Date 03/02/2023

Event Type  malfunction  

Event Description

On (b)(6) 2023 getinge became aware of an issue with the 46-series washer disinfector.As it was stated, there was a water leak from the machine and the operator felt small electrical shock from the soiled side panel in standby condition.The unit was checked with the hospital electrical team.The machine was found to be used with the proper ground.The device was tested with the disinfection cycle and was working fine - no issue was observed.Moreover, it was established that the water leak was caused due to loading trolley alignment issue.It was stated that the event did not lead to any injury, however we decided to report this case based on the potential for a serious injury if the situation was to reoccur.

Manufacturer Narrative

Additional information will be provided following the conlusion of the investigation.Device not returned to the manufacturer.

• 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: dennis genito ; ljungadalsgatan 11; vaxjo
• MDR Report Key: 16500727
• MDR Text Key: 311360666
• Report Number: 9616031-2023-00009
• Device Sequence Number: 1
• Product Code: MEC
• Combination Product (y/n): N
• Reporter Country Code: IN
• 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: 03/08/2023

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
• Device Model Number: 46-5T
• Device Catalogue Number: UNKNOWN
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: 03/02/2023
• Initial Date FDA Received: 03/08/2023
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 08/15/2013
• Is the Device Single Use?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Sex: Prefer Not To Disclose