MAUDE Adverse Event Report: CINCINNATI SUB-ZERO PRODUCTS, INC. CINCINNATI SUB-ZERO; PACK, HOT OR COLD, WATER CIRCULATING

Model Number 300

Device Problem Leak/Splash (1354)

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

Event Date 03/15/2018

Event Type  malfunction  

Event Description

The surgeon needed to use the csz staff vest #300 for cooling purposes at the start of a case.When the cooling unit was turned on, the vest sprayed water out of a defective seam while on the surgeon.The surgeon had to change scrubs.This is a one use only vest and was new out of the package.

• Brand Name: CINCINNATI SUB-ZERO
• Type of Device: PACK, HOT OR COLD, WATER CIRCULATING
• Manufacturer (Section D): CINCINNATI SUB-ZERO PRODUCTS, INC.; 12011 mosteller rd; cincinnati OH 45241
• MDR Report Key: 7428526
• MDR Text Key: 105398095
• Report Number: 7428526
• Device Sequence Number: 1
• Product Code: ILO
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 03/19/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/13/2018
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Model Number: 300
• Device Catalogue Number: 300
• Device Lot Number: 007240
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 03/19/2018
• Device Age: 1 DY
• Event Location: Hospital
• Date Report to Manufacturer: 03/19/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1