inforMED
MalfunctionBTM

SPUR II ADULT RESUSCITATOR

Received Nov 10, 2021 · Event occurred Oct 30, 2021

Report 12786305 · MDR key 12786305

Device

Generic name

Ventilator, Emergency, Manual (resuscitator)

Manufacturer

Ambu A/s

Product problems

  • No Flow
  • Therapeutic or Diagnostic Output Failure

Patient

Unknown

  • Loss of consciousness
  • Low Oxygen Saturation
  • Loss of consciousness
  • Low Oxygen Saturation

Narrative

Description of Event or Problem

PATIENT WAS IN DIALYSIS RECEIVING HER FIRST INTERMITTENT HAEMODIALYSIS RUN AND AN HOUR INTO HER RUN, WENT UNRESPONSIVE (GCS 4). PATIENT STARTED DESATURATING, CLOSE FACE MASK APPLIED AT "FLUSH" RATE. PATIENT STILL UNABLE TO MAINTAIN GOOD SATURATIONS. EMERGENCY AMBU BAG THAT WAS IN ROOM WAS ACCESSED AND HOOKED UP TO OXYGEN, APPLIED OVER MOUTH, HOWEVER THE PATIENT CONTINUED TO DESATURATE DESPITE ATTEMPTING MANUAL BREATHS AND BEING HOOKED UP TO OXYGEN THROUGH AMBU BAG TUBING. PATIENT PLACED BACK ONTO CLOSED FACE MASK AND RRT ARRIVED AT BESIDE. AMBU BAG WAS HOOKED UP TO ANOTHER OXYGEN TREE IN ANOTHER ROOM TO ASSESS QUALITY AND FUNCTION AND WAS FOUND TO BE MALFUNCTIONED, NOT ALLOWING ANY AIR THROUGH THE MASK.