VAC-PAC

Additional Manufacturer Narrative

THE CUSTOMER WAS PROVIDED INFORMATION FOR STORAGE, REPAIR, TESTING AND REPLACEMENT. USERS ARE INSTRUCTED TO CHECK THE VAC PAC DEVICE BEFORE AND AFTER EACH USE AND NOT TO USE THE DEVICE IF THERE IS KNOWN DAMAGE OR A LEAK. USERS ARE ALSO INSTRUCTED TO REPLACE UNITS OLDER THAN TWO YEARS THAT ARE USED SEVERAL TIMES A WEEK.

Description of Event or Problem

THE CUSTOMER INITIALLY CONTACTED NATUS MEDICAL TO REPORT THAT THEIR VAC PAC PATIENT POSITIONING SUPPORT DEVICE'S VALVE STEM IS PULLING OUT. THERE WAS NO REPORT OF DEATH, INJURY OR DELAY IN TREATMENT, AND NO PATIENT INVOLVEMENT WAS REPORTED. THE VAC PAC HAS BEEN REPORTED TO HAVE BEEN PURCHASED MORE THAN THREE YEARS AGO AND HAS BEEN DESTROYED AT THE USER FACILITY.