MAUDE Adverse Event Report: PHILIPS RESPIRONICS I NEB

Device Problem Device Operates Differently Than Expected (2913)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 08/04/2017

Event Type  malfunction  

Event Description

Patient had reported that her i neb was not beeping and the smiley face was not showing when she felt she was finishing treatments.The machine is not a year old so a home health rn went to evaluate the use of the machine.Received call from the home health rn whom evaluated the pt performing a treatment.She states that the pt performed a treatment for 20 minutes (using the gold disk) but the machine never showed a smiley face to indicate the pt completed the treatment.The machine reportedly did vibrate to indicate that it was dispensing med but would not indicate that treatments were completed by showing the smiley face.The home health rn recommended pt be sent a new i neb.No adverse events occurred due to this issue.Sending a new i neb to arrive tomorrow to pt.Dose or amount: 20 mcg/ml.Frequency: 4 treatments/day.Route: inhaled.Dates of use: (b)(6) 2015 to present.Diagnosis or reason for use: pah.

• Brand Name: I NEB
• Type of Device: I NEB
• Manufacturer (Section D): PHILIPS RESPIRONICS
• MDR Report Key: 6800914
• MDR Text Key: 83096037
• Report Number: MW5071643
• 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: Nurse
• Type of Report: Initial
• Report Date: 08/04/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/12/2017
• 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: 75 YR