MAUDE Adverse Event Report: RESPIRONICS RESPIRATORY DRUG DELIVERY I-NEB

Device Problems Component Falling (1105); Device Displays Incorrect Message (2591); Device Operates Differently Than Expected (2913)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 07/16/2017

Event Type  malfunction  

Event Description

Pt dropped i-neb device and device stopped working properly.Device displayed error message 33, which indicates device needs maintenance, but according to operation manual, device should still be operational.New device was couriered to the pt.Pt had already spoken to mfr.Serial number not obtained.Pt has not experienced any ade due to device malfunction.No other info known.Dates of use: (b)(6)2012 to ongoing.Diagnosis or reason for use: pah.

• Brand Name: I-NEB
• Type of Device: I-NEB
• Manufacturer (Section D): RESPIRONICS RESPIRATORY DRUG DELIVERY
• MDR Report Key: 6736137
• MDR Text Key: 80879495
• Report Number: MW5071156
• 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: 07/17/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/20/2017
• 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: 64 YR