MAUDE Adverse Event Report: PHILIPS / RESPIRONICS I-NEB ADD SYSTEM; NEBULIZER (DIRECT PATIENT INTERFACE)

Device Problem Break (1069)

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

Event Date 06/26/2018

Event Type  malfunction  

Event Description

Per the patient, the clip holding down the medication reservoir on the i-neb device broke.Patient did not miss any doses nor did she get harmed by the broken device.The device is being replaced and the patient is aware to hold onto the broken device so it can be returned.Reported to (b)(4) by: patient/caregiver.Dose or amount: 5 mcg, frequency: 6 times per day during waking hours, route: by inhalation, dates of use: from (b)(6) 2016 to current.Diagnosis or reason for use: pah.

• Brand Name: I-NEB ADD SYSTEM
• Type of Device: NEBULIZER (DIRECT PATIENT INTERFACE)
• Manufacturer (Section D): PHILIPS / RESPIRONICS
• MDR Report Key: 7658252
• MDR Text Key: 113242534
• Report Number: MW5078203
• 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: 06/26/2018

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: 07/02/2018
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 69 YR