MAUDE Adverse Event Report: RESPIRONICS I NEB; NEBULIZER (DIRECT PATIENT INTERFACE)

Device Problem Device Displays Incorrect Message (2591)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  malfunction  

Event Description

Patient reports that her pump - sn (b)(4) is giving her an error code of 11.Relayed the troubleshooting solution: stand the i-neb upright on a flat surface.Reset the i-neb by pushing on the button and holding it in.Wait for the start up screen to appear.Pick up i-neb and start your treatment.(code 11 will remain on the screen for 10 minutes or until the on button is pressed for 5 seconds as described above.) pt reports she has tried this already and this did not resolve the issue.She is currently using an older device that she believes she received from a different specialty pharmacy.It seems as if that device is greater than 5 years old though so we are sending a replacement device, so pt can use the new device only.Pt aware and agreeable.She has not missed any doses and not suffered any ill effects from this.Dose or amount: 10mcg/ml.Frequency: 3 sessions/day.Route: inhaled.Dates of use: (b)(6) 2011 to present.Diagnosis or reason for use: pah.

• Brand Name: I NEB
• Type of Device: NEBULIZER (DIRECT PATIENT INTERFACE)
• Manufacturer (Section D): RESPIRONICS
• MDR Report Key: 6897712
• MDR Text Key: 87732220
• Report Number: MW5072491
• 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: 09/21/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/27/2017
• 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