MAUDE Adverse Event Report: ECOLAB/MICROTEK MEDICAL HUSH SLUSH UNIT; SURGICAL SLUSH CONSOLE

Model Number ORS-1075HS

Device Problem Mechanical Problem (1384)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Type  malfunction  

Event Description

It was reported that during an open heart surgery, the fuse assembly of the slush console system had shorted out, sending sparks, smoke and hot metal around the area.The smoke was evacuated by the laminar air system, though some could have entered the surgical field.The console was sequestered.It was noted that the console was 21 years old and had a useful life of over 10 years when used by the facility.No patient complications have been reported as a result of this event.

• Brand Name: HUSH SLUSH UNIT
• Type of Device: SURGICAL SLUSH CONSOLE
• Manufacturer (Section D): ECOLAB/MICROTEK MEDICAL; 1 ecolab place; st paul MN 55102
• Manufacturer Contact: anuli okolo-young ; 1 ecolab place; st paul, MN 55102 ; 6512502237
• MDR Report Key: 8691305
• MDR Text Key: 147731964
• Report Number: 8043817-2019-40025
• 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: health professional,user faci
• Reporter Occupation: Other
• Type of Report: Initial

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
• Was Device Available for Evaluation?: No
• Event Location: Hospital
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 06/12/2019
• Type of Device Usage: Reuse
• Patient Sequence Number: 1