MAUDE Adverse Event Report: PHILIPS RESPIRONICS I-NEB AAD SYSTEM

Model Number 95-149

Device Problems Break (1069); Detachment Of Device Component (1104); Component Falling (1105)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 02/13/2018

Event Type  malfunction  

Event Description

Patient dropped ventavis device and black tab on base where sensor port cover goes broke off.Pt was able to place it back on temporarily and device still functions ok but will need a new device shipped out asap.Pt has not missed his doses.No other information is known.Dose or amount: ventavis 20 mcg/ml.Frequency: ud.Route: inh.Dates of use: (b)(6) 2010 to ongoing.Diagnosis or reason for use: pah.

• Brand Name: I-NEB AAD SYSTEM
• Type of Device: I-NEB
• Manufacturer (Section D): PHILIPS RESPIRONICS
• MDR Report Key: 7276113
• MDR Text Key: 100510673
• Report Number: MW5075289
• 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: 02/13/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/15/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: 95-149
• Is the Reporter a Health Professional?: Yes
• 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: 69 YR