Description of Event or Problem · 1
THIS SPRING, INFANT IN NURSERY STARTING HAVING RESPIRATORY PROBLEMS AND WAS IN NEED OF IMMEDIATE RESUSCITATION. NURSE GRABBED THE NEO TEE DEVICE WHICH IS A SINGLE USE DEVICE. SHE OPENED THE PACKAGE AND APPLIED DEVICE TO BABY. THE DEVICE WOULD NOT FUNCTION. A NEW PACKAGE WAS OPENED AND BABY WAS RESUSCITATED. PRODUCT FAILURE DID DELAY EFFECTIVE RESUSCITATION HOWEVER; NO HARM CAME TO THE BABY. THE MALFUNCTIONING DEVICE WAS THEN INSPECTED. IT WAS FOUND THAT THE MANOMETER MECHANISM WAS NOT ALIGNED PROPERLY. THIS CAME OUT OF THE PACKAGE THAT WAY. IF THE NIPPLE ON THE MANOMETER IS NOT MATED IN THE HOLE AND BODY OF THE RESUSCITATOR PROPERLY, OXYGEN WILL FREE FLOW AND THE RESUSCITATOR WILL NOT WORK PROPERLY. IT WAS REPORTED THAT AFTER INSPECTION OF OTHER UNOPENED UNITS ONE MORE PROBLEM DEVICE WAS FOUND. THIS WAS REPORTED TO THE MANUFACTURER AT THE TIME OF THE EVENT. HOWEVER THIS WAS NOT REPORTED TO OUR RISK OR CLINICAL ENGINEERING DEPARTMENT UNTIL RECENTLY. THEREFORE, WE DO NOT HAVE A LOT NUMBER TO REPORT. AFTER AN INVESTIGATION WAS COMPLETED BY CLINICAL ENGINEERING IT WAS DISCOVERED THE MANUFACTURER HAS NOT RESPONDED BACK TO OUR FACILITY AT THIS TIME.WHAT WAS THE ORIGINAL INTENDED PROCEDURE?NA.DEVICE #1IS THIS A LABORATORY DEVICE OR LABORATORY TEST?NO.