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

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).

• Brand Name: BLANKETROL III
• Type of Device: SYSTEM, THERMAL REGULATING
• Manufacturer (Section D): GENTHERM MEDICAL, LLC.
• MDR Report Key: 12392151
• MDR Text Key: 269394701
• Report Number: MW5103602
• Device Sequence Number: 2
• Product Code: DWJ
• 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: 08/27/2021
• 2 Devices were Involved in the Event: 1 2

1 Patient was Involved in the Event

• Date FDA Received: 08/30/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Is the Reporter a Health Professional?: Yes
• Was Device Evaluated by Manufacturer?: No Information
• Is This a Reprocessed and Reused Single-Use Device?: Yes
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 2 DA
• Patient Weight: 3