Description of Event or Problem · 1
NURSING STAFF IN THE ICU REPORT THAT THEY ARE SEEING PROBLEMS WITH A PIECE ON THE VENTILLATOR CRACKING. ICU STAFF ESTIMATE THEY HAVE SEEN THIS HAPPEN ON AT LEAST 10 PATIENTS. NO PATIENTS WERE HARMED OR HAD CHANGES TO THEIR MEDICAL TREATMENT PLAN. WHEN THE CRACKED ADAPTOR WAS NOTED, RT WAS CALLED TO REPLACE IT. UPON DISCUSSION WITH THE RESPIRATORY THERAPISTS, THE UNIVERSAL CUFF ADAPTOR IS CRACKING. RT STAFF HAVE SEEN THIS OCCUR ON PATIENTS WHO HAVE VARIOUS LEVELS OF HUMIDITY ADDED TO THEIR VENT SETTINGS. IT DOES NOT APPEAR TO BE LOT RELATED AND NOT ALL DEVICES CRACK. UPON FURTHER INVESTIGATION, IT WAS FOUND THAT THE UNIVERSAL CUFF ADAPTOR MADE BY HUDSON RCI HAS A VERY SNUG FIT TO THE END OF THE AEROVENT CHC (COLLAPSIBLE HOLDING CHAMBER). WHILE BOTH DEVICES DO FIT TOGETHER, A SMALL AMOUNT OF FORCE IS REQUIRED TO GET THE ADAPTOR ONTO THE AEROVENT. TO THE END USER, IT APPEARS THAT THESE TWO DEVICES SHOULD WORK TOGETHER. IN A TEST, WE WERE ABLE TO REPRODUCE THE CRACKED UNIVERSAL CUFF ADAPTOR WITHOUT HAVING ANY EQUIPMENT CONNECTED TO A PATIENT AND WITHOUT HAVING A VENTILLATOR IN USE. THE MANAGER OF THE RT DEPARTMENT CONTACTED BOTH COMPANIES. NEITHER HAD PROBLEMS REPORTED WITH THEIR DEVICES. THE AEROVENT REP CAME ON-SITE AND MET WITH THE RT MANAGER AND STAFF. WE HAVE CHANGED TO AN AEROVENT PRODUCT DESIGNED TO FIT ON THE END OF THEIR DEVICE. SINCE THE CHANGE, WE HAVE HAD NO ISSUES WITH CRACKING ADAPTORS.PLEASE NOTE: THE DEVICE LOT NUMBERS AND MODEL NUMBERS PROVIDED IN THIS REPORT ARE FOR THE ONE TEST THAT WE RAN. NO LOT NUMBERS OR OTHER DEVICE SPECIFIC DATA IS AVAILABLE FROM THE OTHER CASES.======================MANUFACTURER RESPONSE FOR VENT CUFF ADAPTOR, UNIVERSAL CUFF ADAPTOR 22MM I.D. (PER SITE REPORTER).======================THE RT DEPARTMENT MANAGER CONTACTED THE MANUFACTURER. THERE HAVE BEEN NO OTHER REPORTED PROBLEMS WITH THIS DEVICE.