inforMED
InjuryKRK

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

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.