TIR-1

Description of Event or Problem

THE CUSTOMER REPORTED THAT THE DEVICE PROVIDES INACCURATE READINGS. THE TIR-1 MEASURED 37.2 DEG C, WHERE A DIFFERENT DEVICE GAVE A READING OF 38 DEG C. THERE WAS NO PATIENT IMPACT OR CONSEQUENCE REPORTED.

Additional Manufacturer Narrative

OTHER, OTHER TEXT: THE RETURNED DEVICE WAS EVALUATED. THE DEVICE WAS FOUND TO HAVE A FOREIGN CONTAMINANT ON THE IR LENS. THIS CAUSES THE TEMPERATURE MEASUREMENTS TO FALL OUTSIDE OF THE ACCEPTABLE RANGE. E1: INITIAL REPORTER PHONE NUMBER EXCEEDED MAXIMUM ALLOWABLE DIGITS, PHONE NUMBER IS AS FOLLOWS: (B)(6).

Description of Event or Problem

THE CUSTOMER REPORTED THAT THE DEVICE PROVIDES INACCURATE READINGS. THE TIR-1 MEASURED 37.2 DEG C, WHERE A DIFFERENT DEVICE GAVE A READING OF 38 DEG C. THERE WAS NO PATIENT IMPACT OR CONSEQUENCE REPORTED.

Additional Manufacturer Narrative

OTHER TEXT: MASIMO HAS REACHED OUT TO THE CUSTOMER TO REQUEST THE RETURN OF THE DEVICE. THE DEVICE HAS NOT BEEN RETURNED TO MASIMO TO ALLOW AN ANALYSIS TO BE PERFORMED. IF THE DEVICE IS RETURNED FOR EVALUATION OR NEW INFORMATION IS OBTAINED, A FOLLOW UP REPORT WILL BE SUBMITTED. THE DEVICE SERIAL NUMBER HAS BEEN REQUESTED AND HAS NOT BEEN OBTAINED, THEREFORE, ONLY THE DEVICE (DI) INFORMATION HAS BEEN POPULATED. E1. INITIAL REPORTER PHONE NUMBER EXCEEDED MAXIMUM ALLOWABLE DIGITS, PHONE NUMBER IS AS FOLLOWS: (B)(6). HEALTH EFFECT IMPACT CODE: NO ADVERSE EVENT; NO PATIENT IMPACT, H3 OTHER TEXT: PRODUCT NOT RETURNED.