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

Model Number 111Z

Device Problems Overheating of Device (1437); Improper or Incorrect Procedure or Method (2017)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 11/16/2021

Event Type  malfunction  

Manufacturer Narrative

(b)(4) received.There were no allegations of patient harm.Device has been returned to gentherm medical and evaluation is pending.

Event 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.

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
• Type of Device: 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
• MDR Text Key: 298924172
• Report Number: 1516825-2022-00002
• Device Sequence Number: 1
• Product Code: DWJ
• UDI-Device Identifier: 10613031861549
• UDI-Public: (01)10613031861549
• Combination Product (y/n): Y
• Reporter Country Code: US
• PMA/PMN Number: K120081
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: User Facility
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 04/18/2002

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/19/2022
• 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
• Date Manufacturer Received: 11/16/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/17/2013
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1