MAUDE Adverse Event Report: MICROTEK MEDICAL INC. HUSH SLUSH UNIT; SURGICAL SLUSH CONSOLE

Model Number ORS-1075HS

Device Problem No Apparent Adverse Event (3189)

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

Event Date 08/28/2020

Event Type  malfunction  

Event Description

It was reported that there was a spark from the slush unit during a case in the (b)(6) operating room.There are no known adverse effects to the patient.

• Brand Name: HUSH SLUSH UNIT
• Type of Device: SURGICAL SLUSH CONSOLE
• Manufacturer (Section D): MICROTEK MEDICAL INC.; microtek medical inc.; columbus MS 39702
• Manufacturer Contact: steven deline ; 1 ecolab place; st. paul, MN 55102 ; 6512503744
• MDR Report Key: 10570318
• MDR Text Key: 209443262
• Report Number: 8043817-2020-00007
• 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,health professional
• Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial
• Report Date: 09/22/2020

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
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 09/22/2020
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/01/2014
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1