CUFF INFLATOR PRESSURE GAUGE WITH CONNECTING TUBES

Additional Manufacturer Narrative

EVALUATION RESULTS: ONE USED/DECONTAMINATED SAMPLE OF A CUFF INFLATOR/PRESSURE GAUGE (100/568/000) WAS RECEIVED WITHOUT ITS ORIGINAL PACKAGING. UNDER VISUAL INSPECTION THE TECHNICIAN OBSERVED THAT THE DISPLAY PROTECTOR WAS MISSING. THE RETURNED UNIT WAS CONNECTED WITH A DIGITAL MANOMETER AND THE RECORDED PRESSURE WAS 31 CM H20, WHICH CORRESPONDED TO A VALUE OF 29 MBAR ON THE DIGITAL MANOMETER. PER SPECIFICATION, THE CUFF PRESSURE GAUGE SHOULD LIE BETWEEN 27 AND 33 CM H2O, AND SHOULD MAINTAIN THIS PRESSURE FOR 10 SECONDS. IT WAS OBSERVED THAT THE CUFF PRESSURE GAUGE FAILED TO MAINTAIN A CONSTANT PRESSURE FOR 10 SECONDS. THERE WAS A 1 MBAR PRESSURE DECREASE APP. EVERY 5 SECONDS. SINCE THE AFFECTED COMPONENT WAS EXTERNALLY PURCHASED FROM A SUPPLIER, A COMPLAINT AGAINST THE SUPPLIER WAS RAISED.

Additional Manufacturer Narrative

MANUFACTURE DATE OF DEVICE UNABLE WITH THE INFORMATION PROVIDED.

Description of Event or Problem

INFORMATION WAS RECEIVED THAT A TEMPORARY VENTILATION FAILURE HAD OCCURED DURING SURGERY ON A PATIENT. IT WAS REPORTED THAT A SMITHS MEDICAL PORTEX CUFF INFLATOR WAS FAULTY, AS IT WAS NOT DEFLATING. VENTILATOR HAD ALARMED "APNOEA" AND ALTHOUGH VENTILATOR BELLOWS WERE FILLING, IT WAS DELIVERING INEFFECTIVE TIDAL VOLUMES AND NO CO2 RECORDED. CUFF MANOMETER ALREADY IN PLACE RECORDING 20CM H2O, BUT ADDITIONAL CUFF INFLATION TO 30CM H2O DID NOT IMPROVE MECHANICAL VENTILATION. A NEW MANOMETER WAS ATTACHED TO ENDOTRACHEAL TUBE CUFF AND RECORDED 10 CM H20, SO CUFF INFLATED TO 30CM H2O AND MECHANICAL VENTILATION SUBSEQUENTLY RESUMED. PATIENT WAS MANUALLY VENTILATED DURING THE INCIDENT. ADEQUATE VENTILATION, OXYGENATION AND DELIVERY OF VOLATILE ANAESTHESIA IN MANUAL MODE FROM THE SAME ANAESTHETIC MACHINE, SO NO SEQUELAE OR DETRIMENT TO THE PATIENT. IT WAS REPORTED THAT A SEPARATE AMBU BAG WAS AVAILABLE FOR VENTILATION SHOULD THAT HAVE FAILED AS WELL. NO PATIENT INJURY RESULTED FROM THE INCIDENT.