MAUDE Adverse Event Report: RESPIRONICS I-NEB DEVICE

Device Problem Device Displays Incorrect Message (2591)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 06/06/2016

Event Type  malfunction  

Event Description

Patient reports that her i-neb device s/n (b)(4) keeps getting error code 55 that can't be resolved with troubleshooting.We will be sending a replacment device.The device caused no harm/side effects/problems to the patient and we will be getting the device returned.Dates of use: from (b)(6) 2013 to present.Diagnosis or reason for use: 127.0.

• Brand Name: I-NEB DEVICE
• Type of Device: I-NEB DEVICE
• Manufacturer (Section D): RESPIRONICS
• MDR Report Key: 5881948
• MDR Text Key: 52496030
• Report Number: MW5064131
• Device Sequence Number: 1
• Product Code: CAF
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Pharmacist
• Type of Report: Initial
• Report Date: 07/06/2016

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: No Information
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 08/11/2016
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 57 YR