inforMED
MalfunctionFOX

VAPOTHERM

Received Jan 4, 2022 · Event occurred Dec 16, 2021

Report 13155224 · MDR key 13155224

Device

Generic name

Stand, Infusion

Manufacturer

Vapotherm, Inc.

Model number

PF-STAND-GCX

Catalog number

PF-STAND-GCX

Product problems

  • Device Tipped Over
  • Detachment of Device or Device Component

Patient

29200 DA · Female

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

Narrative

Description of Event or Problem

THERE WAS A VAPOTHERM HIGH FLOW WITH AIR COMPRESSOR RUNNING. BOTH WERE ATTACHED TO A VAPOTHERM WHEELBASE. THE SET-UP, PARTICULARLY THE POLE OF THE WHEELBASE WITH EVERYTHING ATTACHED, STARTED TO FALL OVER ONTO THE PATIENT. A NURSE WAS PRESENT AND WAS ABLE TO GRAB THE EQUIPMENT BEFORE IT FELL ON TO THE PATIENT. THE MACHINE CONTINUED RUNNING, TREATMENT WAS NOT INTERRUPTED, AND THERE WAS NO HARM TO THE PATIENT. THE MACHINE WAS SWITCHED OUT AND UPON FURTHER INSPECTION IT WAS DETERMINED THAT THE POLE OF THE UNIT DETACHED FROM THE WHEELBASE BECAUSE THE SCREWS ATTACHING THE TWO COMPONENTS WERE SHEARED OFF. WE BELIEVE IT MAY HAVE BEEN THE VIBRATION FROM THE AIR COMPRESSOR THAT CAUSED THIS TO OCCUR. STAFF HAVE BEEN INSTRUCTED TO PLACE THE COMPRESSOR ON THE WHEELBASE TO REDUCE THE AMOUNT OF STRESS ON THE POLE. MANUFACTURER RESPONSE FOR VAPOTHERM: PRECISION FLOW HI-VNI STAND, PRECISION FLOW PLUS STAND (PER SITE REPORTER): THE MANUFACTURER STATED THIS IS THE FIRST TIME THEY HAVE HEARD OF THIS EVENT AND SENT A REPLACEMENT STAND.