ADULT BAGEASY RESUSCITATOR W/PEEP AND MASK
Received Jul 21, 2010 · Event occurred Jun 21, 2010
Report 2028807-2010-00002 · MDR key 1775814
Device
Product problems
- Nonstandard Device
- Unstable
- Component Missing
Patient
Not reported
- No Patient Involvement
Narrative
Description of Event or Problem
NO PATIENT INVOLVEMENT. UPON OPENING, THE CUSTOMER NOTICED THAT THE PRODUCT WAS MISSING THE RETENTION RING AND WAS UNSTABLE. FACILITY PERFORMED STOCK INVESTIGATION AFTER INITIAL REPORT AND FOUND A SECOND UNIT MISSING THE RETENTION RING.
Additional Manufacturer Narrative
ADDITIONAL LOT # 48807. PRODUCT RETURN FROM CUSTOMER CONFIRMED PRODUCT WAS MISSING RETENTION RING AND THUS UNUSABLE. 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. 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.
Remedial action
- Recall