MAUDE Adverse Event Report: PHILIPS RESPIRONICS I-NEB AAD SYSTEM

Model Number I-NEB

Device Problem Break (1069)

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

Event Date 08/17/2017

Event Type  malfunction  

Event Description

Patient dropped her ineb device and a black piece on the inside broke.From the manual, it appears that piece is sensor port cover and it says do not remove.Patient cannot put the piece back on and have it stay on.She did a treatment after this happened and she believes the device is working for now: pharmacy will send replacement device and box to return broken device.Sn (b)(4).No clinical injury reported.Dates of use: from (b)(6) 2013 to current.Diagnosis or reason for use: i27.0.

• Brand Name: I-NEB AAD SYSTEM
• Type of Device: I-NEB
• Manufacturer (Section D): PHILIPS RESPIRONICS
• MDR Report Key: 6820607
• MDR Text Key: 83838182
• Report Number: MW5071794
• 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: 08/17/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/25/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: I-NEB
• 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: 67 YR