MAUDE Adverse Event Report: EXERGEN CORPORATION EXERGEN TEMPORAL SCANNER; 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 02/21/2017

Event Type  malfunction  

Event Description

Temporal scanner used for checking temperature.First reading showed a reading of 39.7, second reading, 39.8.Reported elevated temperature.Sepsis alert fired.New scanner used, temperature read within normal range.

• 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: 6398533
• MDR Text Key: 69762879
• Report Number: 6398533
• 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: 02/28/2017,03/01/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/13/2017
• 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: 02/28/2017
• Event Location: Hospital
• Date Report to Manufacturer: 02/28/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 67 YR
• Patient Weight: 82