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

Model Number TAT5000

Device Problem False Reading From Device Non-Compliance (1228)

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

Event Date 09/04/2017

Event Type  malfunction  

Event Description

Temporal thermometer used and resulted at 100.9, while rectal confirmatory temperature resulted at 99.1.

• Brand Name: TEMPORALSCANNER
• Type of Device: THERMOMETER, ELECTRONIC, CLINICAL
• Manufacturer (Section D): EXERGEN CORPORATION; 400 pleasant street; watertown MA 02472
• MDR Report Key: 6906775
• MDR Text Key: 87870788
• Report Number: 6906775
• 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: User Facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 09/08/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/02/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Nurse
• Device Model Number: TAT5000
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 09/08/2017
• Event Location: Hospital
• Date Report to Manufacturer: 09/08/2017
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1