MAUDE Adverse Event Report: VENTAVIS INEB ADD SYST; NEBULIZER (DIRECT PATIENT INTERFACE)

Device Problems Failure to Charge (1085); Therapeutic or Diagnostic Output Failure (3023)

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

Event Type  malfunction  

Event Description

Received a spontaneous call, per the pt, her ineb device does not beep, treatment times are too long and it is not delivering medication when it is vibrating.A replacement was sent out to the pt for the next morning.Pt did not report any adverse events as a result of the malfunctioning device.Serial # (b)(4).No further details provided.Reported to (b)(6) by pt/caregiver.

• Brand Name: VENTAVIS INEB ADD SYST
• Type of Device: NEBULIZER (DIRECT PATIENT INTERFACE)
• MDR Report Key: 9877813
• MDR Text Key: 185189173
• Report Number: MW5093923
• 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: 03/09/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/24/2020
• 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
• Patient Sequence Number: 1