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

Model Number TAT5000

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

Patient Problems Bacterial Infection (1735); Tachycardia (2095)

Event Date 02/21/2021

Event Type  malfunction  

Event Description

During the day patient had been experiencing tachycardia, temperature was checked by the nursing personnel using a temporal thermometer and the reading were found to be within normal ranges.When pm rn went to do vitals in evening, patient was found to be tachycardic, the temporal thermometer read temp 37.2; but when rn checked temp using an oral thermometer the reading was 38.8c.Md was notified hence blood cultures were obtained which came back positive in less than 24hr for bacterial infection, klebsiella organism.The device was sent to biomed for a check.This event was categorized as minimal temporary harm.This is all the information available.

• Brand Name: TEMPORAL SCANNER
• Type of Device: THERMOMETER, ELECTRONIC, CLINICAL
• Manufacturer (Section D): EXERGEN CORPORATION; 400 pleasant street; watertown MA 02472
• MDR Report Key: 11453017
• MDR Text Key: 238873701
• Report Number: 11453017
• 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: Other Health Care Professional
• Type of Report: Initial
• Report Date: 02/25/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/10/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: TAT5000
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 02/25/2021
• Event Location: Hospital
• Date Report to Manufacturer: 03/10/2021
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Age: 6205 DA