MAUDE Adverse Event Report: PHILIPS RESPIRONICS I-NEB AAD SYSTEM; NEBULIZER (DIRECT PATIENT INTERFACE)

Device Problem Device Alarm System (1012)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 03/14/2018

Event Type  malfunction  

Event Description

Pt's ineb device, serial number (b)(4), is no longer notifying pt when liquid/medication is low in the machine.Pt has not missed any doses or experienced any adverse events.Sending the pt a new ineb device and instructed pt to hold onto current device to be returned once return box is received.Dose or amount: ventavis 5mcg, frequency: 8 times a day, route: inhalation.Dates of use: from (b)(6) 2017 to ongoing.Diagnosis or reason for ues: i27.0, primary pulmonary hypertension.

• Brand Name: I-NEB AAD SYSTEM
• Type of Device: NEBULIZER (DIRECT PATIENT INTERFACE)
• Manufacturer (Section D): PHILIPS RESPIRONICS
• MDR Report Key: 7366149
• MDR Text Key: 103519805
• Report Number: MW5076062
• Device Sequence Number: 1
• Product Code: CAF
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Pharmacist
• Type of Report: Initial
• Report Date: 03/14/2018

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: No Information
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 03/22/2018
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 67 YR