ADULT BAGEASY RESUSCITATOR W/PEEP AND MASK

Additional Manufacturer Narrative

THE LOT NUMBER OF THE DEFECTIVE UNIT WAS NOT AVAILABLE NOR WAS DEFECTIVE PRODUCT. HOWEVER, BASED ON OTHER COMPLAINTS OF A SIMILAR NATURE WHERE LOT NUMBERS WERE KNOWN, WESTMED PERFORMED A DEVICE HISTORY RECORD REVIEW ON THE UNIT WITH THE MISSING RING. THE PROBLEM CAUSING THE DISCONNECTION WAS IDENTIFIED AND TRACED TO A SPECIFIC COMPONENT LOT OF RETENTION RINGS USED. ONCE IDENTIFIED, PRODUCT IN STOCK WAS EVALUATED AND DEFECT CONFIRMED TO EXIST ONLY IN PRODUCT USING THIS LOT OF RETENTION RINGS. WESTMED IS RECALLING ALL OF THE FINISHED GOOD BAG EASY PRODUCTS THAT USED THIS SPECIFIC LOT OF RETENTION RINGS. THE DEFECTIVE PRODUCT IS BELIEVED TO BE ASSOCIATED WITH THE SAME LOT OF RETENTION RINGS. WESTMED HAS UPDATED COMPONENT DRAWINGS FOR THE RETENTION RING TO ENSURE THAT ALL APPROPRIATE DIMENSIONS AND PRODUCT CHARACTERISTICS TO ENSURE PRODUCT FUNCTIONALITY WERE CLEARLY SPECIFIED.

Description of Event or Problem

BAG CAME APART DURING CODE, THERAPIST ASKED FOR A SECOND BAG AND IT WOULD NOT VENTILATE THE PATIENT. INCIDENT OCCURRED DURING THE NIGHT SHIFT AND THE RESPIRATORY THERAPIST INVOLVED DID NOT KEEP ANY PRODUCT INVOLVED WITH THE INCIDENT. PATIENT DIED NINE DAYS AFTER INCIDENT BUT FACILITY IS NOT ATTRIBUTING TO DEVICE MALFUNCTION.