inforMED
DeathKDP

OHIO MEDICAL VACUUM REGULATORS

Received Jan 7, 2022 · Event occurred Jun 11, 2021

Report 13190655 · MDR key 13190655

Device

Generic name

Regulator, Vacuum

Manufacturer

Ohio Medical Llc

Model number

1251

Product problems

  • Defective Device

Patient

28470 DA · Female

  • Vomiting
  • Respiratory Arrest
  • Vomiting
  • Respiratory Arrest

Narrative

Description of Event or Problem

RESPIRATORY ARREST WITH PATIENT HAVING POOLING OF FECULENT VOMIT IN OROPHARYNX. CODE TEAM UNABLE TO EMERGENTLY INTUBATE DUE TO NO FUNCTIONING WALL-SUCTION IN THE ROOM. PER RT (RESPIRATORY THERAPIST) AND NURSING STAFF, SUCTION WAS NOT FUNCTIONING. PORTABLE SUCTION WAS OBTAINED BY RT TEAM, AND PATIENT WAS EVENTUALLY INTUBATED HOWEVER NOT HAVING SUCTION AVAILABLE DURING RESPIRATORY ARREST EVENT DURING EMERGENT INTUBATION WAS A DELAY. DART (DISTRESS ACTIVATION RESPONSE TEAM) WAS CALLED BUT PRIOR TO THEIR ARRIVAL ETT (ENDOTRACHEAL TUBE) WAS PLACED USING PORTABLE SUCTION OBTAINED BY RT. PATIENT ULTIMATELY DIED DESPITE CPR AND RESUSCITATIVE EFFORTS. WALL SUCTION REGULATOR MALFUNCTIONED. WALL SUCTION FUNCTIONING PROPERLY. ENGINEERING REPORTED TO ROOM AND CHECKED THE REPORT OF NO SUCTION. TECH FOUND A BAD SUCTION REGULATOR ON THE WALL TECH, REMOVED THE REGULATOR AND INSTALLED TEST OUR TEST UNIT AND FOUND WALL OUTLET TO BE WORKING CORRECTLY. TECH INFORMED NURSING THEY NEEDED TO CONTACT RESPIRATORY THERAPY FOR A REPLACEMENT UNIT.