inforMED
MalfunctionBTM

VENTLAB

Received Feb 20, 2019 · Event occurred Sep 15, 2018

Report 8353223 · MDR key 8353223

Device

Generic name

Ventilator, Emergency, Manual (resuscitator)

Manufacturer

Ventlab, Llc

Model number

AF1140MB

Catalog number

AF1140MB

Product problems

  • Failure to Disconnect

Patient

22630 DA

  • No Consequences Or Impact To Patient
  • No Consequences Or Impact To Patient

Narrative

Description of Event or Problem

WE WERE IN THE PROCESS OF INTUBATING A PATIENT WHEN WE HAD THE AMBU-BAG CONNECTED TO THE MASK FOR MANUAL BAGGING OF THE PT. RESPIRATORY THERAPIST (RT) WENT TO REMOVE THE MASK PART TO CONNECT TO THE ENDOTRACHEAL TUBE AFTER IT WAS PLACED, AND THE AMBU-BAG WOULD NOT DISCONNECT FROM THE MASK. SHE HAD TO PUT SIGNIFICANT FORCE INTO SEPARATING THE TWO PIECES WHEN THE PIECE COMPLETELY BROKE APART MAKING THE AMBU-BAG USELESS AT THIS TIME. WE QUICKLY WERE ABLE TO GRAB ANOTHER AMBU-BAG WITHIN THE ROOM FOR MANUAL RESPIRATIONS. ZERO PATIENT HARM OCCURRED. THIS HAS OCCURRED IN THE PAST AND WE JUST WANT TO MAKE SURE THIS GOES ON RECORD THAT THIS HAS OCCURRED AGAIN.