MAUDE Adverse Event Report: PHILIPS RESPIRONICS I-NEB; INEB

Device Problems Break (1069); Device Remains Activated (1525)

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

Event Date 02/05/2016

Event Type  Injury  

Event Description

Patient reported that the ventavis ineb is damaged, does not turn off, but she is still continuing with the treatments.No other information is available.Dates of use: from (b)(6) 2013 to current.

• Brand Name: I-NEB
• Type of Device: INEB
• Manufacturer (Section D): PHILIPS RESPIRONICS
• MDR Report Key: 5440642
• MDR Text Key: 38412573
• Report Number: MW5060213
• Device Sequence Number: 1
• Product Code: CAF
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Pharmacist
• Type of Report: Initial
• Report Date: 02/05/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/10/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Is the Reporter a Health Professional?: Yes
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 40 YR