MAUDE Adverse Event Report: CINCINNATI SUBZERO PRODUCTS, LLC (CSZ MEDICAL) MAXI-THERM LITE; PACK, HOT OR COLD, WATER CIRCULATING

Model Number 874

Device Problem Fluid/Blood Leak (1250)

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

Event Date 04/07/2019

Event Type  malfunction  

Event Description

Baby required total body cooling for hypoxic ischemic encephalopathy (hie).When attaching cooling blanket to cooling machine and starting to run the water through, the blanket started leaking.Hoses clamped off and blanket detached and replaced with new blanket.

• Brand Name: MAXI-THERM LITE
• Type of Device: PACK, HOT OR COLD, WATER CIRCULATING
• Manufacturer (Section D): CINCINNATI SUBZERO PRODUCTS, LLC (CSZ MEDICAL); 12011 mosteller rd.; cincinnati OH 45241
• MDR Report Key: 8619296
• MDR Text Key: 145368673
• Report Number: 8619296
• Device Sequence Number: 1
• Product Code: ILO
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 04/12/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/17/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 874
• Device Catalogue Number: 82874
• Device Lot Number: 748019
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 04/12/2019
• Event Location: Hospital
• Date Report to Manufacturer: 05/17/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1