MAUDE Adverse Event Report: PHILIPS I-NEB

Device Problem Application Program Problem (2880)

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

Event Date 11/06/2017

Event Type  malfunction  

Event Description

Pt followed up with i-neb device issue from (b)(6) 2017.Per pt she is having the same issue from monday regardless the use of new mesh.Pt states that she does not feel worse or symptomatic and did not report an adverse event.But is concerned with device's functionality.The device will not trigger the smiley face display.Serial number is (b)(4).Lot number and expiration not available.Return packaging to be sent with order.Pt did not consent to have mfr contact them.Dates of use: from (b)(6) 2016 to ongoing.Diagnosis or reason for use: i27.0 primary pulmonary hypertension.

• Brand Name: I-NEB
• Type of Device: I-NEB
• Manufacturer (Section D): PHILIPS
• MDR Report Key: 7032475
• MDR Text Key: 92175362
• Report Number: MW5073331
• 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: 11/10/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/15/2017
• 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
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 49 YR