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U.S. Department of Health and Human Services

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

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GENTHERM MEDICAL, LLC. BLANKETROL III SYSTEM, THERMAL REGULATING Back to Search Results
Device Problems Increased Sensitivity (2535); Device Sensing Problem (2917); Intermittent Loss of Power (4016)
Patient Problem Insufficient Information (4580)
Event Date 08/26/2021
Event Type  Injury  
Event Description
We have 2 blanketol iii's that have been in use since (b)(6) 2015. Starting (b)(6) 2019 the blanketrols would randomly shut off ¿ company was "never able to replicate" the issue. It continued to happen over the years and they would take them back to inspect and give us loaners (which didn't have issues). The changed the rectal probe cables from the black phone jack to the blue different adapter and that seemed to be working until this past wednesday. When the baby is connected to the machine and rectal probe, and it would rapidly fluctuate the baby's rectal temp reading to the point where it would shut off because the baby was "too cold". This seems to be something with where the temp cable connects to the machine because it's incredibly sensitive and will shut off if the cable is moved. We are unable to get appropriate support or response from the company. Therapy date: (b)(6) 2021. Fda safety report id# (b)(4).
 
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Brand NameBLANKETROL III
Type of DeviceSYSTEM, THERMAL REGULATING
Manufacturer (Section D)
GENTHERM MEDICAL, LLC.
MDR Report Key12392151
MDR Text Key269394701
Report NumberMW5103602
Device Sequence Number1
Product Code DWJ
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Voluntary
Reporter Occupation
Type of Report Initial
Report Date 08/27/2021
2 Devices were Involved in the Event: 1   2  
1 Patient was Involved in the Event
Date FDA Received08/30/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Was Device Available for Evaluation? No Answer Provided
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Was Device Evaluated by Manufacturer?
Is the Device Single Use?
Is This a Reprocessed and Reused Single-Use Device? Yes
Type of Device Usage

Patient Treatment Data
Date Received: 08/30/2021 Patient Sequence Number: 1
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