Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

MAUDE Adverse Event Report: GENTHERM MEDICAL, LLC BLANKETROL III; SYSTEM, THERMAL REGULATING
  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

GENTHERM MEDICAL, LLC BLANKETROL III; SYSTEM, THERMAL REGULATING Back to Search Results
Model Number 233
Device Problem Overheating of Device (1437)
Patient Problem Inadequate Pain Relief (2388)
Event Date 07/10/2022
Event Type  malfunction  
Event Description
Patient was placed on a hypothermia blanket to reduce his temperature, which initially was 105.1 f.The cooling blanket was placed at 0057.I had to call around to all the units, and i finally found one.Np (nurse practitioner) had assessed the patient (pt) this morning.She felt the machine hoses, and immediately noticed that the machine was very hot.Np turned the machine off and immediately made rn (registered nurse) and i aware that the machine was hot.Rn and i removed the blanket from underneath the pt, removed the rectal probe and obtained a rectal temperature which was 102.4f.The machine was completely removed off the patient.Pt's temperatures were as follows: 0320---rectal temp-101.8f, 0411--rectal temp.--102.1, 0438--rectal temp.102.4f, 0500--rectal temp 103.6f, 0700--103.1f.It appears as if there might have been a malfunction with the machine.I touched the machine and i have never felt a hyperthermia/hypothermia blanket that hot.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand Name
BLANKETROL III
Type of Device
SYSTEM, THERMAL REGULATING
Manufacturer (Section D)
GENTHERM MEDICAL, LLC
12011 mosteller rd
cincinnati OH 45241
MDR Report Key15248439
MDR Text Key298146810
Report Number15248439
Device Sequence Number1
Product Code DWJ
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source User Facility
Reporter Occupation Risk Manager
Type of Report Initial
Report Date 08/11/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received08/18/2022
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Other
Device Model Number233
Device Catalogue Number86107
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? No
Was the Report Sent to FDA? Yes
Date Report Sent to FDA08/11/2022
Date Report to Manufacturer08/18/2022
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unknown
Patient Sequence Number1
-
-