Description of Event or Problem · 1
A CUSTOMER REPORTED A VENTILATOR DID NOT RELIEVE PRESSURE AT THE HIGH PRESSURE LIMIT SETTING WHEN IT WAS BEING TESTED PRIOR TO USE. THE FAILURE OF THE DEVICE TO RELIEVE PRESSURE WHEN THE HIGH PRESSURE LIMIT WAS EXCEEDED RESULTED IN THE ACTIVATION OF THE DEVICE'S AUDIO AND VISUAL HIGH PRESSURE ALARMS. WHEN THE DEVICE WAS RETURNED TO AND EVALUATED BY THE MFR, THE VENTILATOR'S DUMP VALVE ASSEMBLY WAS FOUND TO HAVE ITS POWER CONNECTOR PARTIALLY DISLODGED FROM THE VENTILATOR'S POWER BOARD CONNECTOR. THE DUMP VALVE AND POWER BOARD CONNECTORS DID NOT EXHIBIT ANY SIGNS OF DAMAGE AND WHEN RE-CONNECTED WERE FOUND TO ENGAGE AS EXPECTED. TESTING OF THE DEVICE VERIFIED THE PRESSURE LIMIT PROBLEM WAS RESOLVED BY THE RE-CONNECTION OF THE DUMP VALVE ASSEMBLY TO POWER BOARD CONNECTOR. THE MFR CANNOT ASCERTAIN THE CAUSE OF THE DUMP VALVE ASSEMBLY CONNECTOR BECOMING PARTIALLY DISLODGED, HOWEVER THEY DO CONCLUDE THE INTEGRITY OF THE POSITIVE FRICTION LOCK DESIGN OF THE DUMP VALVE ASSEMBLY POWER CONNECTOR OF THIS VENTILATOR IS INTACT, AND THAT THE DESIGN OF THIS CONNECTOR IS ADEQUATE AND NOT RELATED TO THE ISSUE OBSERVED. PRODUCT LABELING FOR THE DEVICE (RESPIRONICS PLV-100 OPERATOR MANUAL, PN 35509) INCLUDES CAUTIONS TO VERIFY THE DEVICE'S FUNCTION BEFORE PLACING IT IN PT USE. THE MFR CONCLUDES THAT THIS PRODUCT LABELING WAS EFFECTIVE AND REQUIRES NO REVISION BECAUSE THE USER IDENTIFIED THE ISSUE DURING VERIFICATION OF THE DEVICE'S FUNCTION PRIOR TO USE, AND TOOK APPROPRIATE ACTION TO RESOLVE THE ISSUE. A REVIEW OF THE MFR'S COMPLAINT DATABASE FOR THE PERIOD JAN 01, 2003 TO SEPT 10, 2008 REVEALED NO INCREASING TRENDS IN COMPLAINT REPORTS OR MDR SUBMISSIONS RELATED TO DUMP VALVE FAILURES AND NO COMPLAINTS OR MDR REPORTS RELATED TO DUMP VALVE ASSEMBLY'S BECOMING DISCONNECTED FROM THE POWER BOARD ASSEMBLY. BASED ON THESE FINDINGS THE MFR CONCLUDES THAT NO FURTHER ACTION IS APPROPRIATE.