MAUDE Adverse Event Report: RESPIRONICS INEB DEVICE; NEBULIZER

Device Problem No Audible Alarm (1019)

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

Event Date 04/01/2016

Event Type  malfunction  

Event Description

Per the pt, her ineb device (b)(4) does not beep or show a smiley face when she is done with her ventavis treatment - the pt is being sent a new device.Dates of use: 2011 to current.Diagnosis or reason for use: pah.

• Brand Name: INEB DEVICE
• Type of Device: NEBULIZER
• Manufacturer (Section D): RESPIRONICS
• MDR Report Key: 5630010
• MDR Text Key: 44461693
• Report Number: MW5062058
• Device Sequence Number: 1
• Product Code: CAF
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Pharmacist
• Type of Report: Initial
• Report Date: 04/28/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/29/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Expiration Date: 04/12/2020
• Is the Reporter a Health Professional?: Yes
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 65 YR