MAUDE Adverse Event Report: ECOLAB/MICROTEK MEDICAL INC ECOLAB; HUSH SLUSH¿ 2.0 ECOLAB SLUSH & WARMER SYSTEM

Model Number	ESW7L
Medical Device Problem Code	Power Problem (3010)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/30/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the auto slush is not working, it does not move when powered on.Slush power button is causing an electric shock when pressed.Customer was not injured from the electrical shock.No patient injuries, infections, or complications were reported.

• Brand Name: ECOLAB
• Common Device Name: HUSH SLUSH¿ 2.0 ECOLAB SLUSH & WARMER SYSTEM
• Manufacturer (Section D): ECOLAB/MICROTEK MEDICAL INC; 1 ecolab place; st. paul MN 55102
• Manufacturer (Section G): MANUFACTURING ONE; 14851 stonecroft center ct.; chantilly VA 20151
• Manufacturer Contact: yarina montas ; 1 ecolab place; st. paul, MN 55102
• MDR Report Key: 20506856
• Report Number: 3013401749-2024-00001
• Device Sequence Number: 12862213
• Product Code: LHC
• UDI-Device Identifier: 50748426126731
• UDI-Public: 50748426126731
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: User Facility,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 10/14/2024

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
• Device Model Number: ESW7L
• Device Lot Number: ESW00231, ESW00263
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/30/2024
• Initial Report FDA Received Date: 10/22/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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: Unknown
• Patient Sequence Number: 1
• Patient Sex: Unknown