MAUDE Adverse Event Report: PHILIPS RESPIRONICS I-NEB INHALATION DEVICE

Device Problems Device Operates Differently Than Expected (2913); Noise, Audible (3273)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 10/07/2016

Event Type  malfunction  

Event Description

Pt reports a whistling and whirring of the device when administering her ventavis.This did occur when she was using the device, but did not cause any adverse event or missed dose.Device to be replaced.

• Brand Name: I-NEB INHALATION DEVICE
• Type of Device: I-NEB INHALATION DEVICE
• Manufacturer (Section D): PHILIPS RESPIRONICS; murrysville PA
• MDR Report Key: 6066683
• MDR Text Key: 59012537
• Report Number: MW5065691
• 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: 10/07/2016

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: 10/25/2016
• Type of Device Usage: N
• Patient Sequence Number: 1
• Treatment: VENTAVIS
• Patient Age: 63 YR