VAC-PAC
Received Jan 17, 2018
Report 3018859-2018-00050 · MDR key 7201991
Device
Product problems
- Air Leak
- Use of Device Problem
- Torn Material
- Air Leak
- Use of Device Problem
- Torn Material
Patient
Not reported
- No Known Impact Or Consequence To Patient
- No Known Impact Or Consequence To Patient
Narrative
Description of Event or Problem
N/A
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 CUT NEAR THE CORNER. THERE WAS NO REPORT OF DEATH, INJURY OR DELAY IN TREATMENT, AND NO PATIENT INVOLVEMENT WAS REPORTED. CUSTOMER HAS BEEN ADVICE TO DESTROYED VAC PAC AT THE USER FACILITY.
Remedial action
- Replace