VAC-PAC

Additional Manufacturer Narrative

THE CUSTOMER WAS PROVIDED INFORMATION FOR STORAGE, REPAIR, TESTING AND REPLACEMENT, AND THE CUSTOMER OPTED TO REPLACE THEIR VAC PAC UNDER WARRANTY. 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 LEAKS AT THE VALVE STEM. 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 IN (B)(6) 2017 AND HAS BEEN DESTROYED AT THE USER FACILITY.