MAUDE Adverse Event Report: GENTHERM MEDICAL, LLC BLANKETROL; SYSTEM, THERMAL REGULATING

Model Number 876

Device Problem Leak/Splash (1354)

Patient Problem Insufficient Information (4580)

Event Date 03/17/2021

Event Type  malfunction  

Event Description

Leak noted in blanketrol blanket prior to incision but after induction.Patient moved to cart.New blanket placed.

• Brand Name: BLANKETROL
• Type of Device: SYSTEM, THERMAL REGULATING
• Manufacturer (Section D): GENTHERM MEDICAL, LLC; 12011 mosteller rd.; 3rd floor; cincinnati OH 45241
• MDR Report Key: 11588330
• MDR Text Key: 242932607
• Report Number: 11588330
• Device Sequence Number: 1
• Product Code: DWJ
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 03/17/2021

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: 876
• Device Lot Number: 18634
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 03/17/2021
• Event Location: Hospital
• Date Report to Manufacturer: 03/30/2021
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 03/30/2021
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Age: 15695 DA