MAUDE Adverse Event Report: EXERGEN CORPORATION EXERGEN TEMPORAL SCANNER; THERMOMETER, ELECTRONIC, CLINICAL

Model Number TAT5000

Patient Problem Fever (1858)

Event Date 09/02/2023

Event Type  malfunction  

Event Description

Patient was warm to touch throughout the day.Temporal temperatures checked q4hr, all within normal limits.During change of shift report, this registered nurse (rn) and oncoming rn repositioned patient together.Took temporal temperature together since oncoming nurse noticed warmth as well.Temp read 99f.This rn suggested taking a rectal temperature.Rectal temperature taken, read 104.7f.Doctor notified immediately.

• Brand Name: EXERGEN TEMPORAL SCANNER
• Type of Device: THERMOMETER, ELECTRONIC, CLINICAL
• Manufacturer (Section D): EXERGEN CORPORATION; 400 pleasant street; watertown MA 02472
• MDR Report Key: 18649534
• MDR Text Key: 334627589
• Report Number: 18649534
• 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: 10/25/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/06/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Model Number: TAT5000
• Device Catalogue Number: 124375, 124374, 124375-R
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 10/25/2023
• Event Location: Hospital
• Date Report to Manufacturer: 02/06/2024
• Type of Device Usage: Unknown
• Patient Sequence Number: 1