SMITHS MEDICAL PORTEX HYPERINFLATION RESUSCITATION MANOMETERS
Received Aug 19, 2019 · Event occurred Jul 15, 2019
Report 3012307300-2019-04040 · MDR key 8906419
Device
Generic name
Manometer, Blood-pressure, Venous
Manufacturer
Smiths Medical Asd, Inc.Product problems
- No Device Output
- Unable to Obtain Readings
- No Device Output
- Unable to Obtain Readings
Patient
Not reported
- Low Oxygen Saturation
- Low Oxygen Saturation
Narrative
Description of Event or Problem
INFORMATION WAS RECEIVED THAT DURING VERIFICATION OF THE CUFF OF A SMITHS MEDICAL PORTEX ENDOTRACHEAL TUBE, THE MANOMETER INDICATED "ZERO PRESSURE" WHILE THE CUFF APPEARED TO BE OVER INFLATED. THIS OCCURRED ONCE AGAIN ON THE SECOND ATTEMPT. ON THE THIRD TEST WITH A DIFFERENT MANOMETER, IT ALSO INDICATED "ZERO PRESSURE". WHILE TESTING THE THIRD TIME, THE USER NOTED THE TRACHEAL TUBE HAD CAUSED HAEMODYNAMIC LABILITY ON LEAKS OF FORENE SOLUTION, AND THE BENCHMARK TRACHEAL TUBE HAD SLIPPED TWO CENTIMETERS. IMMEDIATELY, PATIENT WAS SECURED FOR REPOSITIONING OF THE TRACHEAL TUBE AND REINTUBATION. THE PATIENT WAS THEN STABILIZED.