MAUDE Adverse Event Report: KAZ USA, INC, A HELEN OF TROY COMPANY BRAUN TOUCHLESS THERMOMETER; THERMOMETER, ELECTRONIC, CLINICAL

Model Number BNT 400

Device Problem Display or Visual Feedback Problem (1184)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 07/15/2020

Event Type  malfunction  

Event Description

Used a newly purchased braun touchless thermometer to record temperature for covid 19 screening and there was an error in the readings displayed.Repeated the temperature scan on the forehead and thermometer consistently read 95.6-96.6, while the mercury thermometer was reading between 101.2-102.4.I called the manufacturer to inquire if the units had to be calibrated and if so how to do so and was told that they are self calibrated and they would send me a replacement in the mail.Fda safety report id # (b)(4).

• Brand Name: BRAUN TOUCHLESS THERMOMETER
• Type of Device: THERMOMETER, ELECTRONIC, CLINICAL
• Manufacturer (Section D): KAZ USA, INC, A HELEN OF TROY COMPANY
• MDR Report Key: 10407064
• MDR Text Key: 203155985
• Report Number: MW5096063
• 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: Unknown
• Type of Report: Initial
• Report Date: 08/11/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/13/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: BNT 400
• Device Lot Number: 08720TAV
• Was Device Available for Evaluation?: Yes
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 53 YR
• Patient Weight: 78