PORTEX CUFF PRESSURE MONITORING

Additional Manufacturer Narrative

THIS MDR WAS GENERATED UNDER PROTOCOL (B)(4), AS A RESULT OF WARNING LETTER CMS# (B)(4). A PRODUCT SAMPLE WAS RECEIVED FOR EVALUATION. VISUAL AND FUNCTIONAL TESTING WERE PERFORMED. UNDER VISUAL INSPECTION THE SAMPLE APPEARED TO BE IN GOOD CONDITION. RETURNED DEVICE PASSED ALL TESTING BOTH ACCURACY AND NO PRESSURE DROP AND DIGITAL MANOMETER. BASED ON ABOVE FUNCTIONAL TESTING REPORTED FAILURE WAS NOT OBSERVED. NO ROOT CAUSE WAS FOUND DUE TO NO FAULT BEING FOUND. NO ACTION WAS NEEDED.

Description of Event or Problem

IT WAS REPORTED THAT THE PRODUCT (A CUFF PRESSURE GAUGE) WAS USED FOR A PATIENT WHO HAD A TRACHEOSTOMY. DURING THE USE OF IT, LEAKAGE OF AIR FROM IT WAS OBSERVED, WHICH CAUSED THE INDICATION NEEDLE TO GO DOWN. NO PATIENT INJURY.