FLEXIFIT HC405 NASAL MASK

Description of Event or Problem

BROKEN ELBOW TABS. DETERMINED TO BE A TAB STYLE CONNECTOR. THERE WAS NO PT INJURY REPORTED.

Additional Manufacturer Narrative

METHOD: DEVICE NOT AVAILABLE. RESULTS: WE BECAME AWARE THAT A CONNECTOR COMPONENT USED IN A PREVIOUS VERSION OF ITS CPAP MASK MAY FAIL PREMATURELY IF IMPROPERLY CLEANED. PLASTIC TABS INCORPORATED INTO THE CONNECTOR COMPONENTS OF THESE CPAP MASKS MAY BREAK OFF IF THEY ARE NOT CLEANED IN ACCORDANCE WITH OUR INSTRUCTIONS FOR USE. CONCLUSION: FISHER & PAYKEL HEALTHCARE IS CURRENTLY CONDUCTING A RETAIL LEVEL RECALL ON ALL TAB DESIGNED CONNECTORS FOR CPAP MASKS. WE ARE CURRENTLY AWAITING CLASSIFICATION OF THE FISHER & PAYKEL HEALTHCARE CPAP MASK AND CONNECTORS RECALL FROM FDA. ALL PRODUCT MANUFACTURED SINCE APRIL 2006 FEATURES A REDESIGNED CONNECTOR AND IS NOT SUBJECT TO THIS RECALL.