SYNCLARA COUGH SYSTEM

Additional Manufacturer Narrative

THE BAXTER TECHNICIAN FOUND THE PATIENT CIRCUIT KIT NEEDED TO BE REPLACED. A SEARCH OF THE BAXTER MAINTENANCE RECORDS DID NOT SHOW BAXTER PERFORMED ANY PREVENTATIVE MAINTENANCE ON THIS DEVICE. IT IS UNKNOWN IF THE FACILITY PERFORMS PREVENTATIVE MAINTENANCE ON THEIR DEVICE. THE SYNCLARA COUGH SYSTEM IS INTENDED FOR USE ON PATIENTS WHO ARE UNABLE TO COUGH OR CLEAR SECRETIONS EFFECTIVELY DUE TO REDUCED PEAK COUGH EXPIRATORY FLOW OR RESPIRATORY MUSCLE WEAKNESS. THE SYNCLARA COUGH SYSTEM PROVIDES A NONINVASIVE THERAPY DESIGNED FOR USE BY PATIENTS, CAREGIVERS, AND HEALTHCARE PROVIDERS. THE SYSTEM WILL SIMULATE A COUGH TO REMOVE SECRETIONS IN PATIENTS WITH A COMPROMISED PEAK COUGH FLOW. POSSIBLE ADVERSE CONDITIONS LISTED IN THE DEVICE INSTRUCTIONS FOR USE INCLUDE SWALLOWING TOO MUCH AIR RESULTING IN THE LIKELIHOOD OF VOMITING AND ASPIRATION. THE USE OF A FACE MASK MAY RESULT IN DISCOMFORT, VOMITING, OR BREATHLESSNESS IN SOME PATIENTS. CLOSE SUPERVISION THROUGHOUT THE TREATMENT IS NECESSARY WHEN THIS PRODUCT IS USED BY CHILDREN OR PATIENTS WITH PHYSICAL LIMITATIONS OR IMPAIRED COGNITIVE ABILITIES. THE TECHNICIAN REPLACED THE PATIENT CIRCUIT KIT TO RESOLVE THE REPORTED EVENT. BASED ON THIS INFORMATION, NO FURTHER ACTION IS REQUIRED.

Description of Event or Problem

BAXTER RECEIVED A REPORT THAT SYNCLARA SYSTEM, NON-FT SW,HC,NA HAD CRACKED FILTER. THIS OCCURRED AT HOME DURING PATIENT USE. THERE WAS NO PATIENT INJURY OR DEATH REPORTED WITH THIS EVENT.