MAUDE Adverse Event Report: PARI VORTEX NEVH CHAMBER

Model Number 051D0215

Device Problem Labelling, Instructions for Use or Training Problem (1318)

Patient Problem No Information (3190)

Event Date 01/21/2016

Event Type  Other  

Event Description

The instructions in the vortex spacer by pari were wrong.Illustration #2 of 3 on the side of the spacer (which is illustration #3 of 6 on the downloaded pdf instructions) incorrectly shows shaking the inhaler while it is attached to the spacer; this is wrong and unnecessarily cumbersome.The inhaler should be shaker by itself and then attached to the spacer.It also does not show when the pressing down of the inhaler is to begin before or simultaneously with breathing in.The breathing in correctly should begin afterwards, not simultaneously; this may be key for people who have low lung capacity and weak inhaling capability, the reason for taking an inhaler! also, the people at pari were not too helpful nor knowledgeable at their customer service line, which i can detail.

• Brand Name: VORTEX NEVH CHAMBER
• Type of Device: VORTEX NEVH CHAMBER
• Manufacturer (Section D): PARI
• MDR Report Key: 5396773
• MDR Text Key: 37096785
• Report Number: MW5059722
• 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: 01/21/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/21/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: 051D0215
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 66 YR
• Patient Weight: 118