VAC-PAC
Received Feb 6, 2018
Report 3018859-2018-00091 · MDR key 7245399
Device
Product problems
- Air Leak
- Air Leak
Patient
Not reported
- No Known Impact Or Consequence To Patient
- No Known Impact Or Consequence To Patient
Narrative
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.
Description of Event or Problem
THE CUSTOMER CONTACTED NATUS MEDICAL TO REPORT THAT THEIR VAC-PAC PATIENT POSITIONING SUPPORT DEVICE HAD A SLOW LEAK AT THE VALVE. 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 IN (B)(6) 2015 AND HAS BEEN DESTROYED AT THE USER FACILITY.
Remedial action
- Replace