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. 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 OR UNITS THAT HAVE BEEN PATCHED MORE THAN ONCE.

Description of Event or Problem

THE CUSTOMER CONTACTED NATUS MEDICAL TO REPORT THAT THEIR VAC-PAC PATIENT POSITIONING SUPPORT DEVICE HAD SEVERAL SMALL CUTS THAT WERE PATCHED AND THE DEVICE WAS LEAKING. THERE WAS NO REPORT OF DEATH, INJURY OR DELAY IN TREATMENT, AND NO PATIENT INVOLVEMENT WAS REPORTED. THE VAC-PAC DEVICE HAS BEEN REPORTED TO HAVE BEEN PURCHASED OVER THREE YEARS AGO AND HAS BEEN DESTROYED AT THE USER FACILITY.