MAUDE Adverse Event Report: WELCH ALLYN, INC. WELCH ALLYN, INC.; THERMOMETER, ELECTRONIC, CLINICAL

Model Number 901053

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

Patient Problem Insufficient Information (4580)

Event Date 06/15/2022

Event Type  malfunction  

Event Description

Thermometer readings were consistently 2 degrees celsius higher than the actual temperature.The error was found when another thermometer was used and provided the accurate reading.

• Brand Name: WELCH ALLYN, INC.
• Type of Device: THERMOMETER, ELECTRONIC, CLINICAL
• Manufacturer (Section D): WELCH ALLYN, INC.; 4341 state street rd; skaneateles falls NY 13153
• MDR Report Key: 14929018
• MDR Text Key: 295320677
• Report Number: 14929018
• Device Sequence Number: 1
• Product Code: FLL
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 07/01/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/06/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 901053
• Device Catalogue Number: 01692-000
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 07/01/2022
• Device Age: 3 YR
• Event Location: Hospital
• Date Report to Manufacturer: 07/06/2022
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Age: 21 DA
• Patient Sex: Male