MAUDE Adverse Event Report: PHILLIPS RESPIRONICS I-NEB AAD SYSTEM 20 MCG/ML

Device Problems Device Alarm System (1012); Fluid/Blood Leak (1250); Failure to Deliver (2338); Device Displays Incorrect Message (2591)

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

Event Date 07/07/2016

Event Type  malfunction  

Event Description

Patient stated that during her last treatment yesterday, her i-neb stopped delivering treatments after 2 breaths and when she put the device down, it started to beep and leak.Patient stated that she put in new medicine, re-assembled the entire device (she also took out and reinserted the disc), went to restart her treatment and the same thing occurred.Patient stated that she is adequately proficient in assembling her device and assured (b)(4) it wasn't a "user" issue.(b)(4) voiced understanding and asked if the machine gave an error code, and she said it gave her code 22.(b)(4) then attempted to troubleshoot with patient per the user guide but she stated she was not home and that she had "tried everything".(b)(4) voiced understand and informed her that a new i-neb will be sent to her.She denied any current or previous side effects from being unable to complete her last dose from yesterday.She also was at dialysis at the time of the call, and had not tried to do a treatment today, as she does treatments post dialysis on mondays, wednesdays, and fridays.(b)(4) also informed that a return box will be sent to.Dose or amount: 5 mcg 9 times a day on, inhaled; 5 mcg 6 times a day on mondays, inhaled.Dates of use: from (b)(6) 2013 to ongoing.

• Brand Name: I-NEB AAD SYSTEM 20 MCG/ML
• Type of Device: I-NEB
• Manufacturer (Section D): PHILLIPS RESPIRONICS
• MDR Report Key: 5946028
• MDR Text Key: 54662105
• Report Number: MW5064696
• Device Sequence Number: 1
• Product Code: CAF
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 07/08/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 09/07/2016
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 1960 YR