inforMED
MalfunctionCAG

ADULT BI-PAP SINGLE LIMB HEATED WIRE B/S 1.6M (KIT 1)

Received Jun 27, 2024 · Event occurred Jun 2, 2024

Report 3006061749-2024-00024 · MDR key 19622241

Device

Generic name

Circulator, Breathing-circuit

Catalog number

038-31-601U

Product problems

  • Moisture or Humidity Problem
  • Moisture or Humidity Problem

Patient

NA · Unknown

  • No Clinical Signs, Symptoms or Conditions
  • No Clinical Signs, Symptoms or Conditions

Narrative

Description of Event or Problem

EVENT AS DESCRIBED BY COMPLAINANT: "I WAS IN ROOM 219 TODAY (B)(6) 2024 STANDING NEXT TO THE VENTILATOR GETTING SET UP TO DO TRACH CARE. THERE WAS VERY MINIMAL CONDENSATION IN THE VENT CIRCUIT. EVERYTHING APPEARED NORMAL IN THAT ASPECT. THEN ALL OF A SUDDEN THE ENTIRE WATER CHAMBER FILLED UP FAST AND ALL OF THE WATER RUSHED UP THE Y OF THE PATIENT CIRCUIT. THE ENTIRE INSPIRATORY SIDE OF THE CIRCUIT SEEMED TO BE FULL OF WATER. I IMMEDIATELY HELD THE CIRCUIT UP SO THE WATER WOULD GO BACK AWAY FROM THE PATIENT WHILE SUCTIONING AS THE NURSE TURNED ON THE AMBU BAG. THE VENT WAS PLACED IN STAND BY AND DISCONNECTED FROM THE PATIENT. RT (B)(6) WAS CALLED WHILE I BAGGED THE PATIENT AND A NEW CHAMBER/CIRCUIT WAS SET UP AND SST'D. PATIENT WAS THEN PLACED BACK ON THE VENT. RT LEAD (B)(6) SAVED THE CHAMBER/CIRCUIT BECAUSE WE BELIEVE IT WAS A CHAMBER FAILURE. THE WATER BAG WAS HALF FULL AND HAD NOT BEEN CHANGED OR ANYTHING SINCE SHIFT CHANGE. NOTHING WAS LEAKING ON THE VENT THAT I WAS AWARE OF; OR DISCONNECTED. I WAS NOT EVEN TOUCHING THE PATIENT OR VENT RIGHT WHEN THIS HAPPENED HAD I NOT BEEN STANDING THERE AS THIS HAPPENED IT WOULD HAVE DROWNED THE PATIENT".

Remedial action

  • Replace