MAUDE Adverse Event Report: TEMP PROBE; THERMOMETER, ELECTRONIC, CLINICAL

Model Number 900MR869

Device Problem Moisture or Humidity Problem (2986)

Patient Problem Nasal Obstruction (2466)

Event Date 05/27/2022

Event Type  malfunction  

Event Description

Temp probe was malfunctioning with the hfov circuit having less humidity than it should, with the infant developing the mucus plug.Fda safety report id# (b)(4).

• Brand Name: TEMP PROBE
• Type of Device: THERMOMETER, ELECTRONIC, CLINICAL
• MDR Report Key: 15067705
• MDR Text Key: 296374483
• Report Number: MW5111006
• Device Sequence Number: 1
• Product Code: FLL
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: No Information
• Type of Report: Initial
• Report Date: 07/18/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/19/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 900MR869
• Device Lot Number: 2101503080
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Patient Sequence Number: 1
• Patient Age: 5 DA
• Patient Sex: Male