HC431NIV

Description of Event or Problem

PATIENT EXPERIENCED SKIN REDNESS AND BURNING REACTION ON FACIAL AREA, AFTER USING A RE-PROCESSED FULL FACE NIV (NON-INVASIVE VENTILATOR) MASK FOR 4 HOURS. NO PERMANENT INJURY, NO MEDICAL INTERVENTION REQUIRED.

Additional Manufacturer Narrative

THE FLEXIFIT HC431NIV FULL FACE MASK WAS RE-PROCESSED USING A CHEMICAL DISINFECTANT (LYSETOL AF2%) NOT RECOMMENDED IN USER INSTRUCTIONS AND THEREFORE, NOT VALIDATED FOR USE ON FISHER & PAYKEL HEALTHCARE MASKS. PLEASE REFER TO CURRENT REVISION OF FOREIGN USER INSTRUCTIONS ENCLOSED FOR DETAILS ON APPROVED MULTI-PATIENT CLEANING TECHNIQUES FOR HC431NIV MASKS. HOSPITAL ADMITTED THAT THEY USED AN UN-APPROVED CLEANING DISINFECTANT TO CLEAN MASK, PRIOR TO USE ON PATIENT AND STATED THAT THE PATIENT SKIN REACTION WAS POTENTIALLY, AS A RESULT OF OVER EXPOSURE TO DISINFECTANT DURING CLEANING. THE PATIENT WAS SAID TO HAVE SENSITIVE SKIN. PLEASE NOTE-HC431NIV IS NOT CURRENTLY AVAILABLE, HOWEVER, ALL FISHER & PAYKEL HEALTHCARE CPAP MASKS ARE OF SIMILAR DESIGN TO THE NIV RANGE AND ARE ALSO VALIDATED FOR RE-USE ACCORDING TO SIMILAR DISINFECTION TECHNIQUES.