MAUDE Adverse Event Report: MASIMO CORPORATION; THERMOMETER, ELECTRONIC, CLINICAL

Model Number TIR-1

Device Problems High Readings (2459); Low Readings (2460)

Patient Problems Fever (1858); Alteration in Body Temperature (4568)

Event Date 09/14/2022

Event Type  malfunction  

Event Description

"patient scanned from masimo new thermometer read 97.0.Pt cold to touch, oral temp taken and read 93.7.Rectal temp read 94.7." "forehead thermometer not working.Keeps reading 97.6 while pt has been running high fevers." manufacturer response for thermometer, (brand not provided) (per site reporter) they are evaluating.

• Type of Device: THERMOMETER, ELECTRONIC, CLINICAL
• Manufacturer (Section D): MASIMO CORPORATION; 15750 alton parkway; irvine CA 92618
• MDR Report Key: 15592627
• MDR Text Key: 301736251
• Report Number: 15592627
• 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: Biomedical Engineer
• Type of Report: Initial
• Report Date: 09/22/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/12/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: TIR-1
• Device Catalogue Number: TIR-1
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 09/22/2022
• Event Location: Hospital
• Date Report to Manufacturer: 10/11/2022
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1