MAUDE Adverse Event Report: GENTHERM MEDICAL, LLC NORM-O-TEMP

Model Number	111Z
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/16/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4) received.There were no allegations of patient harm.Device has been returned to gentherm medical and evaluation is pending.
Event or Problem Description
The customer states that the unit overheated.The unit was in the operating room, prepping for a paitent but was never used for the paitent.The unit was left on and running overnight without oversight.The customer noticed that the unit had caused damage to itself and to objects around the device.The customer claims that they did not discover the unit malfunction until the next day.
Additional Manufacturer Narrative
Device was evaluated by gentherm.The issue was confirmed.Gentherm concludes that there were 6 faults with the device.The most probable cause was a low water condition with a simultaneous float switch fault, and a failure of the device to shut down the heater.This is the first instance a device had an extreme overheating event.

• Brand Name: NORM-O-TEMP
• Common Device Name: NORM-O-TEMP
• Manufacturer (Section D): GENTHERM MEDICAL, LLC; 12011 mosteller rd; cincinnati OH 45241
• Manufacturer (Section G): GENTHERM MEDICAL, LLC; 12011 mosteller rd; cincinnati OH 45241
• Manufacturer Contact: angie gegner ; 12011 mosteller rd; cincinnati, OH 45241 ; 5133265228
• MDR Report Key: 14141356
• Report Number: 1516825-2022-00002
• Device Sequence Number: 4961265
• Product Code: DWJ
• UDI-Device Identifier: 10613031861549
• UDI-Public: (01)10613031861549
• Combination Product (Y/N): Y
• Initial Reporter State: MN
• Initial Reporter Country: US
• PMA/510(K) Number: K120081
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: User Facility
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 04/18/2002

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Model Number: 111Z
• Device Catalogue Number: 86154
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/22/2022
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/16/2021
• Supplement Date Received by Manufacturer: 11/16/2021
• Initial Report FDA Received Date: 04/19/2022
• Supplement Report FDA Received Date: 07/15/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/17/2013
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown