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

Device Problem Failure to Shut Off (2939)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 07/02/2018

Event Type  malfunction  

Event Description

Pt states ventavis device does not stop after treatment.Does not miss therapy.Pt did not have serial number of device.No more info given.Serial number: pt did not have it.Name of the part the pt is having an issue with or error code displaying no error code.Just won't shut off.Please document, in the description whether or not an averse event is associated with the product complaint.Pt did not miss therapy, no adverse event.Dates of use: from (b)(6) 2016 to present.Diagnosis or reason for use: i27.0.

• Brand Name: I-NEB AAD SYSTEM
• Type of Device: NEBULIZER (DIRECT PATIENT INTERFACE)
• Manufacturer (Section D): RESPIRONICS, INC.
• MDR Report Key: 7689358
• MDR Text Key: 114141706
• Report Number: MW5078411
• 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: 07/03/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/13/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 37 YR