MAUDE Adverse Event Report: PARI RESPIRATORY EQUIPMENT, INC. VIOS LC PLUS COMPRESSOR; NEBULIZER (DIRECT PATIENT INTERFACE)

Device Problem Mechanical Problem (1384)

Patient Problem No Code Available (3191)

Event Date 10/17/2018

Event Type  malfunction  

Event Description

Pt's mother reports using vios lc plus compressor with daughter's bethkis stating she believes she received a "dud." mother states that it takes 30 mins for pt to receive medication and compressor does not work sufficiently.

• Brand Name: VIOS LC PLUS COMPRESSOR
• Type of Device: NEBULIZER (DIRECT PATIENT INTERFACE)
• Manufacturer (Section D): PARI RESPIRATORY EQUIPMENT, INC.
• MDR Report Key: 8151120
• MDR Text Key: 130169950
• Report Number: MW5082009
• Device Sequence Number: 1
• Product Code: CAF
• UDI-Device Identifier: 83490031067
• UDI-Public: 83490-0310-67
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Pharmacist
• Type of Report: Initial
• Report Date: 12/07/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 12/10/2018
• Was Device Evaluated by Manufacturer?: No Information
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 29 MO