VAC-PAC
Received Jan 24, 2018
Report 3018859-2018-00061 · MDR key 7215650
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 INITIALLY CONTACTED NATUS MEDICAL TO REPORT THAT THEIR VAC PAC PATIENT POSITIONING SUPPORT DEVICE HAD A PINHOLE THAT LEAKS. 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) 2016 HAS BEEN DESTROYED AT THE USER FACILITY.
Remedial action
- Replace