MAUDE Adverse Event Report: PHILLIPS/RESPIRONICS, INC VENTAVIS I-NEB AAD SYSTEM; NEBULIZER (DIRECT PATIENT INTERFACE)

Device Problem No Flow (2991)

Patient Problem Dizziness (2194)

Event Date 11/19/2018

Event Type  Injury  

Event Description

Received spontaneous call from the patient, stating her i-neb device is not working.The medication chamber is secure, she changed the disc but after running the device for 30+ minutes, nothing is coming out and the chamber is still full.Sending her a new device for tomorrow morning.Due to only getting 4 of 8 doses, patient stated she started to feel dizzy.Non-working i-neb device serial number (b)(4).Reported to (b)(6) by: patient/caregiver.

• Brand Name: VENTAVIS I-NEB AAD SYSTEM
• Type of Device: NEBULIZER (DIRECT PATIENT INTERFACE)
• Manufacturer (Section D): PHILLIPS/RESPIRONICS, INC
• MDR Report Key: 8343855
• MDR Text Key: 137113020
• Report Number: MW5084131
• Device Sequence Number: 1
• Product Code: CAF
• Combination Product (y/n): Y
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 11/19/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/14/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Expiration Date: 11/15/2022
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Patient Sequence Number: 1
• Patient Age: 52 YR