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

Model Number 233

Device Problems Temperature Problem (3022); Therapeutic or Diagnostic Output Failure (3023)

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

Event Date 04/30/2022

Event Type  malfunction  

Event Description

Blanketrol was set to auto control because patient was cool.However, when baby got too cold, the blanketrol claimed to be warming up but it was not warming up.Blanketrol was switched out.

Event Description

Blanketrol was set to auto control because patient was cool.However, when baby got too cold, the blanketrol claimed to be warming up but it was not warming up.Blanketrol was switched out.

• Brand Name: BLANKETROL
• Type of Device: SYSTEM, THERMAL REGULATING
• Manufacturer (Section D): GENTHERM MEDICAL, LLC; 12011 mosteller rd.; cincinnati OH 45241
• MDR Report Key: 14631038
• MDR Text Key: 293536842
• Report Number: 14631038
• 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,Followup
• Report Date: 05/05/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/08/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Model Number: 233
• Device Catalogue Number: 52440
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 05/05/2022
• Event Location: Hospital
• Date Report to Manufacturer: 06/08/2022
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Age: 1 DA
• Patient Sex: Male