OHIO CONTINUOUS SUCTION REGULATOR

Description of Event or Problem

IT WAS REPORTED THE WHEN A NEWBORN POST-TERM BABY WAS BEING TREATED FOR MECONIUM ASPIRATION, THE SUBJECT DEVICE FAILED TO PROVIDE SUCTION WHEN NEEDED. THE HOSPITAL REPORTED THAT THE PATIENT SUSTAINED PERMANENT BRAIN DAMAGE. THE ALLEGED INCIDENT TOOK PLACE MORE THAN A YEAR PRIOR TO OHMEDA'S NOTIFICATION, WHICH OCCURRED IN CONJUNCTION WITH THE HOSPITAL'S REQUEST FOR A MANUAL. THE HOSPITAL HAD DISCARDED THE MANUAL THAT ACCOMPANIED THE PRODUCT WHEN IT WAS ORIGINALLY RECEIVED. THE HOSPITAL ALSO STATED THAT IT HAS A MAINTENANCE CONTRACT WITH AN OUTSIDE SERVICE COMPANY WHICH PERFORMS CORRECTIVE MAINTENANCE, BUT DOES NOT PERFORM PREVENTIVE MAINTENANCE ON THEIR EQUIPMENT.