MAUDE Adverse Event Report: TYCO HEALTHCARE GROUP, LP / CARDINAL HEALTH GENIUS 2 INFRARED TYMPANIC ELECTRONIC THERMOMETER; THERMOMETER, ELECTRONIC, CLINICAL

Model Number 303000

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

Event Type  malfunction  

Event Description

When we turned on the laser to do the test it took more than one minute to see the heat rise up.After a minute and a half we turned the laser off and we started to see the heat rising up.Water was all the time running at the highest flow.We did see for several seconds the heat still rising up and it took like a minute to go down.There is a delay on thermography.This report reflects information received by fda in the form of a notification per 803.22 (b)(2).

• Brand Name: GENIUS 2 INFRARED TYMPANIC ELECTRONIC THERMOMETER
• Type of Device: THERMOMETER, ELECTRONIC, CLINICAL
• Manufacturer (Section D): TYCO HEALTHCARE GROUP, LP / CARDINAL HEALTH
• MDR Report Key: 18058765
• MDR Text Key: 327371470
• Report Number: MW5147659
• Device Sequence Number: 1
• Product Code: FLL
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Unknown
• Type of Report: Initial
• Report Date: 10/30/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/01/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Model Number: 303000
• Patient Sequence Number: 1