Description of Event or Problem · 0
MASIMO SET LNCS NEO SPO2 NEONATAL/ADULT PULSE OXIMETER ADHESIVE SENSOR WITH BATCH NUMBER 24EN9 ARE NOT RECOGNIZED BY WELCH ALLYN CONNEX VITAL SIGN MONITOR AND CONNEX INTEGRATED WALL SYSTEM RUNNING P3 HARDWARE. MASIMO LNCS NEO SPO2 SENSORS, WITH LOT #¿S MANUFACTURED AFTER JANUARY 2024, ARE NOT WORKING WITH THE WELCH ALLYN CONNEX MONITORS WITH HARDWARE VERSION P3. WELCH ALLYN P3 HARDWARE VERSION INCLUDES ALL DEVICES MANUFACTURED BEFORE 11/2017 AS PER WELCH ALLYN SERVICE BULLETIN 80022414 CSB-CVSM/CIWS IEC 60601 4TH EDITION. ALL MASIMO DISPOSABLE SENSOR MANUFACTURED IN OR PRIOR TO YEAR 2023 ARE WORKING CORRECTLY. APPARENTLY, MASIMO CHANGED ITS MANUFACTURING FACILITY FROM MEXICO TO MALAYSIA AS ALL DISPOSABLE SENSORS WITH LOT NUMBERS STARING WITH THE NUMBER 24 ARE COMING FROM MALAYSIA. SENSORS WITH LOT NUMBERS STARING WITH 23 OR BELOW ARE COMING FROM MEXICO. WHEN YOU CONNECT THE NEW SENSOR WITH LOT NUMBERS STARTING WITH A 24 TO THE WELCH ALLYN UNITS, IT IS NOT RECOGNIZED AND ERROR ¿REPLACE THE SPO2 SENSOR¿ SHOWS ON THE SCREEN. MANUFACTURER RESPONSE FOR OXIMETER, MASIMOSET LNCS NEO NEONATAL/ADULT PULSE OXIMETER ADHESIVE SENSOR (PER SITE REPORTER) LOCAL MASIMO REP HAS TAKEN A SAMPLE OF THE DISPOSABLE WITH THE ISSUE, AND THEY ARE INVESTIGATING.