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

Model Number TIR

Device Problem Temperature Problem (3022)

Patient Problem Alteration in Body Temperature (4568)

Event Date 03/18/2023

Event Type  malfunction  

Event Description

Masimo temporal thermometer read 97.9 at two separate times.Pt felt physically hotter to touch.Rectal temperature subsequently taken and resulted at 100.6 and 100.3 respectively.Manufacturer response for temporal thermometer, (brand not provided), (per site reporter).

• Type of Device: THERMOMETER, ELECTRONIC, CLINICAL
• Manufacturer (Section D): MASIMO CORPORATION; 15750 alton parkway; irvine CA 92618
• MDR Report Key: 16681439
• MDR Text Key: 312687756
• Report Number: 16681439
• 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: 03/23/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/05/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: TIR
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 03/23/2023
• Device Age: 1 YR
• Event Location: Hospital
• Date Report to Manufacturer: 04/05/2023
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1