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

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).

• Brand Name: BLANKETROL III GENTHERM
• Type of Device: SYSTEM, THERMAL REGULATING
• Manufacturer (Section D): GENTHERM MEDICAL, LLC; cincinnati OH 45241
• MDR Report Key: 12861564
• MDR Text Key: 281214919
• Report Number: MW5105520
• Device Sequence Number: 1
• Product Code: DWJ
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Nurse
• 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 Received: 11/22/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: REF 233 FOR BOTH MACHINES
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 1 DA
• Patient Sex: Prefer Not To Disclose