inforMED
MalfunctionBTC

PORTEX

Received Jul 29, 2020 · Event occurred May 23, 2020

Report 10337637 · MDR key 10337637

Device

Generic name

Bag, Reservoir

Model number

C45091773D-NL

Product problems

  • Material Split, Cut or Torn

Patient

18980 DA

  • No Known Impact Or Consequence To Patient
  • No Known Impact Or Consequence To Patient

Narrative

Description of Event or Problem

PATIENT BROUGHT TO OPERATING ROOM AND ANESTHESIA WAS INDUCED PER ROUTINE. WHEN WE ATTEMPTED TO VENTILATE THE PATIENT WITH THE GREEN VENTILATION BAG ON THE ANESTHESIA MACHINE, IT RIPPED. THIS CAUSED US TO BE UNABLE TO VENTILATE THE PATIENT AS USUAL. BECAUSE THIS OR IS A DESIGNATED COVID OPERATING ROOM, ALL EXTRA SUPPLIES HAD BEEN REMOVED, INCLUDING SPARE ANESTHESIA CIRCUITS. IT TOOK SEVERAL MINUTES FOR A RUNNER TO RETRIEVE A REPLACEMENT PART. LUCKILY, WE WERE ABLE TO VENTILATE THE PATIENT BY ALTERNATIVE MEANS, BUT THIS COULD HAVE LED TO A CATASTROPHIC EVENT.