LIFEGUARD RESUSCITATION BAG

Description of Event or Problem

BAG WAS NOT MECHANICALLY SOUND. 02 TUBE DISCONNECTED SELF FROM END OF BAG AT COMPLETION OF RESUSCITATION. IS SUPPOSED TO BE GLUED IN PLACEDEVICE LABELED FOR SINGLE USE. PATIENT MEDICAL STATUS PRIOR TO EVENT: CRITICAL CONDITION. THERE WAS NOT MULTIPLE PATIENT INVOLVEMENT.INVALID DATA - ON DEVICE SERVICE/MAINTENANCE. NO DATA - REGARDING DATE LAST SERVICED. SERVICE PROVIDED BY: INVALID DATA. INVALID DATA - SERVICE RECORDS AVAILABILITY. INVALID DATA - REGARDING WHETHER EVENT PRESENTS IMMINENT HAZARD. DEVICE USED AS LABELED/INTENDED.DEVICE WAS EVALUATED AFTER THE EVENT. METHOD OF EVALUATION: ACTUAL DEVICE INVOLVED IN INCIDENT WAS EVALUATED, VISUAL EXAMINATION. RESULTS OF EVALUATION: MANUFACTURING, MECHANICAL PROBLEM, NONE OR UNKNOWN, OTHER, OTHER. CONCLUSION: DEVICE FAILED DURING ASSEMBLY, DEVICE FAILURE RELATED TO PATIENT CONDITION. CERTAINTY OF DEVICE AS CAUSE OF OR CONTRIBUTOR TO EVENT: MAYBE. CORRECTIVE ACTIONS: DEVICE PERMANENTLY REMOVED FROM SERVICE, USE OF ALL SIMILAR DEVICES STOPPED PERMANENTLY. INVALID DATA - ON DEVICE DESTROYED/DISPOSED OF STATUS.