MAUDE Adverse Event Report: BRAUN WELCH ALLYN / KAZ USA, INC. TYMPANIC THERMOMETER BRAUN WELCH ALLYN; THERMOMETER, ELECTRICAL, CLINICAL

Device Problem High Test Results (2457)

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

Event Date 07/01/2019

Event Type  malfunction  

Event Description

Tympanic thermometer was noted to be reading falsely high as checked by oral thermometer.Fda safety report id# (b)(4).

• Brand Name: TYMPANIC THERMOMETER BRAUN WELCH ALLYN
• Type of Device: THERMOMETER, ELECTRICAL, CLINICAL
• Manufacturer (Section D): BRAUN WELCH ALLYN / KAZ USA, INC.
• MDR Report Key: 8785436
• MDR Text Key: 151028156
• Report Number: MW5088050
• 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: Nurse
• Type of Report: Initial
• Report Date: 07/09/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/11/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was Device Evaluated by Manufacturer?: No Information
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1