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

Model Number	TAT5000
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	09/18/2018
Type of Reportable Event	Malfunction
Event or Problem Description
Vital signs taken, temperature recorded of 103.1 and medicated with prn order.Discovered later that the thermometer was reading inadequately on all patients.Called biomed to take equipment.When tested with calibrated tester the thermometer was found to be off by 1 degree fahrenheit.Accuracy is +/-.2 degrees fahrenheit.Device will be returned to manufacturer for exchange.

• Brand Name: EXERGEN TEMPORAL SCANNER
• Common Device Name: THERMOMETER, ELECTRONIC, CLINICAL
• Manufacturer (Section D): EXERGEN CORPORATION; 400 pleasant street; watertown MA 02472
• MDR Report Key: 7909499
• Report Number: 7909499
• Device Sequence Number: 19182344
• Product Code: FLL
• UDI-Device Identifier: 10834098000089
• UDI-Public: (01)10834098000089
• Combination Product (Y/N): N
• Initial Reporter State: RI
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: User Facility
• Initial Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date (Section B): 09/20/2018
• Report Date (Section F): 09/20/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: TAT5000
• Device Catalogue Number: 124275, 124276, 124275-R
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/18/2018
• Was the Report Sent to FDA?: Yes
• Event Location: Hospital
• Date Report to Manufacturer: 09/26/2018
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 09/26/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Date Report Sent to FDA: 09/20/2018