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

Model Number 901053

Device Problem Output Problem (3005)

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

Event Date 02/16/2020

Event Type  malfunction  

Event Description

Axillary temperature performed on patient in triage bay by patient care associate, initially read 98.6 f.Axillary temperature performed on patient in exam room by nurse, read 101.4 f.

• Brand Name: WELCH ALLYN, INC.
• Type of Device: THERMOMETER, ELECTRONIC, CLINICAL
• Manufacturer (Section D): WELCH ALLYN, INC.; 4341 state street road; skaneateles falls NY 13153
• MDR Report Key: 10008911
• MDR Text Key: 189315233
• Report Number: 10008911
• 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: Risk Manager
• Type of Report: Initial
• Report Date: 04/21/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/29/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: 901053
• Device Catalogue Number: 01692-000
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 04/21/2020
• Event Location: Hospital
• Date Report to Manufacturer: 04/29/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1