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U.S. Department of Health and Human Services

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

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GENTHERM MEDICAL, LLC BLANKETROL III GENTHERM SYSTEM, THERMAL REGULATING Back to Search Results
Model Number REF 233 FOR BOTH MACHINES
Device Problems Therapeutic or Diagnostic Output Failure (3023); Unexpected Shutdown (4019)
Patient Problem Insufficient Information (4580)
Event Date 11/18/2021
Event Type  Injury  
Event Description
We have 2 blanketrol iii units from gentherm that have failed. We had two previous units that also failed and i'd filed a report with medwatch on 8/27/2021. After that the company switched our units to the two that we currently have on the unit. Both of these machines have failed multiple times while in use on neonates. There are two different things happening - sometimes they spontaneously shut off, others the rectal temp fluctuates so greatly and rapidly that the machine alarms and stops functioning until the unit is reset. Fda safety report id# (b)(4).
 
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Brand NameBLANKETROL III GENTHERM
Type of DeviceSYSTEM, THERMAL REGULATING
Manufacturer (Section D)
GENTHERM MEDICAL, LLC
cincinnati OH 45241
MDR Report Key12861564
MDR Text Key281214919
Report NumberMW5105520
Device Sequence Number2
Product Code DWJ
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Voluntary
Reporter Occupation
Type of Report Initial
Report Date 11/18/2021
2 Devices were Involved in the Event: 1   2  
1 Patient was Involved in the Event
Date FDA Received11/22/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberREF 233 FOR BOTH MACHINES
Was Device Available for Evaluation? No Answer Provided
Is the Reporter a Health Professional? Yes
Is This a Reprocessed and Reused Single-Use Device? No

Patient Treatment Data
Date Received: 11/22/2021 Patient Sequence Number: 1
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