MAUDE Adverse Event Report: MASIMO - 15750 ALTON PKWY TIR-1 THERMOMETER; THERMOMETER, ELECTRONIC, CLINICAL

Model Number 38581

Device Problem Incorrect Measurement (1383)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 09/14/2022

Event Type  malfunction  

Manufacturer Narrative

The returned device was evaluated.The device was able to obtain measurements however failed accuracy testing due to contamination on the ir lens.Contaminant was unable to be fully cleaned from ir lens.

Event Description

Per medwatch: "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." no known consequences or impact to patient were reported.

• Brand Name: TIR-1 THERMOMETER
• Type of Device: THERMOMETER, ELECTRONIC, CLINICAL
• Manufacturer (Section D): MASIMO - 15750 ALTON PKWY; 15750 alton pkwy; irvine CA 92618
• Manufacturer (Section G): MASIMO - MEXICALI; industrial vallera de mexicali calzada del oro, no.2001; mexicali, baja california 21600 ; MX 21600
• Manufacturer Contact: matofa fautua ; 15750 alton pkwy; irvine, CA 92618 ; 9498223661
• MDR Report Key: 15654559
• MDR Text Key: 302243524
• Report Number: 3019388613-2022-00225
• Device Sequence Number: 1
• Product Code: FLL
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K131771
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other
• Reporter Occupation: Biomedical Engineer
• Remedial Action: Other
• Type of Report: Initial
• Report Date: 10/11/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 38581
• Device Catalogue Number: 4301
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/26/2022
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 10/11/2022
• Initial Date FDA Received: 10/21/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/11/2020
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1