MAUDE Adverse Event Report: RESPIRONICS INC. INHALATION DEVICE

Model Number UNABLE TO PROVIDE.

Device Problem Charging Problem (2892)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  malfunction  

Event Description

Ventavis: patient reports that her ineb device is not holding a charge, and when she places the device to charge, the battery indicator never reaches a full charge.Battery and power cord are being replaced.Patient states that she has not missed any treatments as a result of the issue and patient has not had any adverse reactions as a result of the problem.Patient unable to provide any lot or serial number for battery or power cords.Ac# for patient: (b)(4).Product has not yet been returned to the pharmacy, but is available if required.Patient did not provide consent for the manufacturer to contact them directly in regards to the product.Dates of use: from (b)(6) 2012 to ongoing.Diagnosis or reason for use: pah.(b)(6).

• Brand Name: INHALATION DEVICE
• Type of Device: INHALATION DEVICE
• Manufacturer (Section D): RESPIRONICS INC.
• MDR Report Key: 5966190
• MDR Text Key: 55423129
• Report Number: MW5064893
• 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

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/15/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: UNABLE TO PROVIDE.
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Device Usage: N
• Patient Sequence Number: 1