MAUDE Adverse Event Report: PARI RESPIRATORY EQUIPMENT, INC. VIOS AEROSOL DELIVERY SYSTEM; NEBULIZER (DIRECT PATIENT INTERFACE)

Model Number 310B0003

Device Problems Fluid/Blood Leak (1250); Loose or Intermittent Connection (1371); Device Difficult to Setup or Prepare (1487); Product Quality Problem (1506); Patient Device Interaction Problem (4001)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 07/08/2022

Event Type  malfunction  

Event Description

Vios aerosol delivery system is flawed.The reasons are as follows: in the hospital, they had put the nebulizer on my face and i just had to breathe.When this unit was delivered, there is no such thing at all.The nebulizer outlet has to be held in hand to get the medicine.For a sick person over 70 years old, holding on for about fifteen minutes is not that simple.You could at least supply a strap to hold the nebulizer.It does not take five but a full fifteen minutes or more to inhale the complete prescribed medicine dose.Loading the medicine in the nebulizer: for an elderly sick person, it is almost impossible to put the medicine in the nebulizer without spilling.I have loaded it three times and two times i have lost the medicine.The holder fit is very loose.Unless it is put in with extra care, it does not hold the nebulizer.Can you not design a better holder and clip in the machine? when you put on the holder, there is no space at the bottom and so you have to bend the tube.Because of this, the tubing will be damaged after it has been used just a few times.Can you not give an extra inch or so for the nebulizer tubing at the bottom? this unit is designed for a young thirty-year-old healthy but not for an old sick person.I have already talked to and conveyed this information to the supplier, (b)(4) here in (b)(6).Unfortunately, they carry only this brand.Otherwise, i would have returned it.You say that your registration card is the simplest in the world but your actual unit is one of the worst in the world designed for this purpose.You are forcing me to click on "acknowledge the information".This is not the way to hear from customers.Fda safety report id # (b)(4).

• Brand Name: VIOS AEROSOL DELIVERY SYSTEM
• Type of Device: NEBULIZER (DIRECT PATIENT INTERFACE)
• Manufacturer (Section D): PARI RESPIRATORY EQUIPMENT, INC.
• MDR Report Key: 15042989
• MDR Text Key: 296142078
• Report Number: MW5110908
• Device Sequence Number: 1
• Product Code: CAF
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Patient
• Type of Report: Initial
• Report Date: 07/13/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/15/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: 310B0003
• Was Device Available for Evaluation?: Yes
• Patient Sequence Number: 1
• Treatment: ADVAIR; ALBUTEROL ; IRON ; VITAMIN C; VITAMIN D
• Patient Age: 73 YR
• Patient Sex: Male
• Patient Weight: 50 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: Asian