MAUDE Adverse Event Report: PARI RESPIRATORY EQUIPMENT, INC. VORTEX NON ELECTROSTATIC VALVED HOLDING CHAMBER

Model Number 051F6000

Device Problems Sticking (1597); Failure to Deliver (2338)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 01/06/2017

Event Type  malfunction  

Event Description

Vortex holding chamber is a "spacer" to be used with metered dose inhalers.I received a brand new one today in sealed packaging.The "duckbill" valve in the device is one-way to allow air passage during the inhalation phase of use.This valve was stuck shut so no medication could be inhaled.I had to take the device mouthpiece apart to physically separate the leaves on the valve to make it work.I suffered no injury, but a patient trying to use a similarly defective device could be seriously harmed, especially if the inhaled drug is intended to open airways in asthma.

• Brand Name: VORTEX NON ELECTROSTATIC VALVED HOLDING CHAMBER
• Type of Device: VORTEX NON ELECTROSTATIC VALVED HOLDING CHAMBER
• Manufacturer (Section D): PARI RESPIRATORY EQUIPMENT, INC.; 2412 pari way; midlothian VA 23112
• MDR Report Key: 6237811
• MDR Text Key: 64525654
• Report Number: MW5067156
• Device Sequence Number: 1
• Product Code: CAF
• 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: 01/07/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/07/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: 051F6000
• Device Catalogue Number: 83490-0510-25
• Device Lot Number: 042315
• Was Device Available for Evaluation?: Yes
• Type of Device Usage: N
• Patient Sequence Number: 1