RD RAINBOW LITE SET-1 NEO ADH

Additional Manufacturer Narrative

OTHER, 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. HEALTH EFFECT IMPACT CODE: NOT ENOUGH INFORMATION PROVIDED TO DETERMINE PATIENT IMPACT.

Description of Event or Problem

THE CUSTOMER REPORTED A CONCERN OF SLOW RESPONSE IN READING OF SPO2 AND PULSE RATE PARAMETERS. "THIS ISSUE CONTINUES TO PERSIST. YESTERDAY, WE EXPERIENCED AN EMERGENCY CASE WHERE A BABY WAS BORN, AND THE MACHINE FAILED TO PICK UP THE FHR AND SPO2. IT TOOK NEARLY SEVEN MINUTES BEFORE ANY DATA APPEARED, AND EVEN THEN, THE READINGS DID NOT ACCURATELY REFLECT THE BABY'S CONDITION. GIVEN THE SERIOUSNESS OF SUCH DELAYS DURING NEONATAL RESUSCITATION."