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

Device Problem Unable to Obtain Readings (1516)

Patient Problem Insufficient Information (4580)

Event Date 09/06/2021

Event Type  malfunction  

Event Description

While in use, the thermometer was unable to read temperatures.

• Brand Name: WELCH ALLYN THERMOMETER
• Type of Device: THERMOMETER, ELECTRONIC, CLINICAL
• Manufacturer (Section D): WELCH ALLYN INC.; 4341 state street road; skaneateles falls NY 13153
• MDR Report Key: 12525836
• MDR Text Key: 273149034
• Report Number: 12525836
• 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: 09/14/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/24/2021
• 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?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 09/14/2021
• Event Location: Hospital
• Date Report to Manufacturer: 09/22/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1