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

Device Problem Incorrect, Inadequate or Imprecise Result or Readings (1535)

Patient Problem Insufficient Information (4580)

Event Date 01/21/2022

Event Type  malfunction  

Event Description

A (b)(6) male admitted on (b)(6) 2021 with sob and covid 19.On (b)(6) 2022, the patients temperature was checked with a tympanic thermometer for a reading of 40.1.The provider was notified, asa and iv fluid bolus administered.When the same thermometer was used on a different patient it gave the same reading.It was at that time that it was realized the thermometer could be malfunctioning.The device was not checked by clinical engineering because the staff discarded it.Fda safety report id# (b)(4).

• Brand Name: WELCH BRAUN TYMPANIC THERMOMETER
• Type of Device: THERMOMETER, ELECTRONIC, CLINICAL
• Manufacturer (Section D): KAZ USA, INC., A HELEN OF TROY COMPANY
• MDR Report Key: 13366386
• MDR Text Key: 284632898
• Report Number: MW5107002
• 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: Risk Manager
• Type of Report: Initial
• Report Date: 01/24/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/26/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 76 YR
• Patient Sex: Male
• Patient Weight: 53 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White