VAC-PAC

Additional Manufacturer Narrative

NO DEVICE MALFUNCTION HAS BEEN REPORTED IN THIS COMPLAINT, BUT A POTENTIAL INJURY INVOLVING THE VAC-PAC DEVICE HAS BEEN REPORTED TO NATUS. THE CUSTOMER HAS BEEN CONTACTED ON 4/5/2018, 4/16/2018 AND 4/19/2018. NO ADDITIONAL INFORMATION SURROUNDING THE EVENT HAS BEEN PROVIDED. CUSTOMERS ARE 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 REPORTED TO THE NATUS TECHNICAL SERVICE REP (TSR) THAT A PATIENT APPEARED TO HAVE DIFFICULTY WITH ONE OF HIS LEGS AFTER A SURGICAL PROCEDURE INVOLVING A VAC-PAC. THE CUSTOMER DID NOT KNOW THE EXACT DIAGNOSIS BUT IT APPEARED TO BE MUSCULOSKELETAL OR NEUROLOGICAL IN NATURE. THE CUSTOMER STATED SHE WAS NOTIFIED BY AN OPERATING ROOM EDUCATOR THAT THE INCIDENT HAPPENED APPROXIMATELY "A WEEK OR TWO AGO." NO INFORMATION REGARDING SIZE OR LOT NUMBER WAS REPORTED. SHE STATED THE MALE PATIENT WAS UNDERGOING A SHOULDER SURGERY AND WAS PLACED IN THE LATERAL POSITION. THE CUSTOMER ALSO CONFIRMED THE VAC-PAC STAYED FIRM THROUGHOUT THE SURGERY. THE MALE PATIENT HAS BEEN REPORTED TO BE (B)(6)., AND THE DURATION OF THE SURGERY IS UNKNOWN. THERE HAS BEEN NO REPORT OF DEATH, SERIOUS INJURY OR DELAY IN TREATMENT. NO ENVIRONMENTAL CONCERNS HAVE ALSO BEEN REPORTED.