MAUDE Adverse Event Report: ECOLAB/MICROTEK MEDICAL INC. HUSH SLUSH; HUSH SLUSH UNIT

Model Number ORS-1075HS

Device Problem Noise, Audible (3273)

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

Event Date 10/28/2021

Event Type  malfunction  

Event Description

It was reported that there was a malfunction caught before use of the unit.The malfunction reported was an unusual sound and abnormal smell coming from the unit.No patient injury or infection was reported.

• Brand Name: HUSH SLUSH
• Type of Device: HUSH SLUSH UNIT
• Manufacturer (Section D): ECOLAB/MICROTEK MEDICAL INC.; 1 ecolab pl; st. paul MN 55102
• Manufacturer (Section G): MFG ONE, LLC; 14851 stonecroft center ct; chantilly VA 20151
• Manufacturer Contact: emily scott ; 1 ecolab pl; st. paul, MN 55102
• MDR Report Key: 12837952
• MDR Text Key: 286991478
• Report Number: 1043582-2021-00002
• Device Sequence Number: 1
• Product Code: LHC
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Consumer,User Facility
• Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial
• Report Date: 11/18/2021

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 Operator: Health Professional
• Device Model Number: ORS-1075HS
• Device Lot Number: NOT PROVIDED
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 10/28/2021
• Initial Date FDA Received: 11/18/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1