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

Model Number TAT5000

Device Problem Incorrect, Inadequate or Imprecise Result or Readings (1535)

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

Event Date 09/18/2018

Event Type  malfunction  

Event 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
• Type of Device: THERMOMETER, ELECTRONIC, CLINICAL
• Manufacturer (Section D): EXERGEN CORPORATION; 400 pleasant street; watertown MA 02472
• MDR Report Key: 7909499
• MDR Text Key: 121728872
• Report Number: 7909499
• Device Sequence Number: 1
• Product Code: FLL
• UDI-Device Identifier: 10834098000089
• UDI-Public: (01)10834098000089
• 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: 09/20/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/26/2018
• Is this a Product Problem Report?: Yes
• Device Operator: 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
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 09/20/2018
• Event Location: Hospital
• Date Report to Manufacturer: 09/26/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1