Description of Event or Problem · 1
AMBU INFANT RESUSCITATOR BAGS CAME APART AT FIRST JOINT ON TWO CONSECUTIVE DAYS OF PREPARING FOR C-SECTIONS. SECOND DAY PRE-TEST OF BAG SETUP WAS DONE BY RESPIRATORY TECH AND PEDIATRICIAN. FOLLOWING BIRTH OF INFANT VIA C-SECTION, AMBU BAG CAME APART BEFORE IT COULD BE USED FOR INFANT. MOUTH TO MOUTH WAS GIVEN FOR RESUSCITATION OF THE NEWBORN. THE NEWBORN DID WELL AND NO PROBLEMS WERE IDENTIFIED. THE AMBU BAD DEVISES WERE NOT USED ON EITHER OF THE SECTIONED INFANTS BUT WAS NEEDED ON THE SECOND SECTION DATE OF 2007. AMBU COMPANY NOTIFIED OF PROBLEM WITH AMBU INFANT BAGS AND SENDS LOCAL REPRESENTATIVE TO COLLECT AND REPLACE ALL BAGS. COMPANY QA PERSON REPORTS BAG REDESIGNED LAST YEAR WITH A AMBU SPUR 11, NOT AS A DESIGN FLAW BUT DUE TO ROUTINE UPGRADE, ADDITIONS OF FEATURES AND DUE TO THE REVISION IN AHA GUIDELINES. NO RECALL WAS MADE ON THE AMBU SPUR 1 FOR THIS REASON. THE ROUTINE PURCHASE ORDERS FOR OUR FACILITY SINCE LAST YEAR WAS FILLED WITH AMBU SPUR 1 AND NOT THE SPUR II UPGRADE. AS RECENT AS TWO DAYS EARLIER, A CASE OF THE AMBU SPUR 1 WAS RECEIVED BECAUSE THE PURCHASING MANAGER WAS ORDERING FROM ORDER NUMBERS THAT WERE ON HAND AND NOT FOR THE AMBU COMPANY UPGRADE. AMBU WAS TO INVESTIGATE THE DEVICE COMPLAINT AND REPORTS THIS IS AN ISOLATED INCIDENCE. QUESTION TO REPORT OR NOT REPORT THE ALLEGED ISOLATED USE WITH AMBU INFANT BAGS.