MAUDE Adverse Event Report: PHILIPS RESPIRONICS / RESPIRONICS RESPIRATORY DRUG DELIVERY (UK) LTD. INEB; NEBULIZER

Device Problem Break (1069)

Patient Problem No Information (3190)

Event Date 07/17/2018

Event Type  malfunction  

Event Description

The pt's wife called in to let us know the disc slot on the ineb device is broken.A replacement device is being sent out, so the pt does not have to hold onto the disc during his ventavis treatment.Dose or amount: 5mcg; frequency: 6 times a day; route: by mouth.Dates of use: from (b)(6) 2013 to current.Diagnosis or reason for use: pah.

• Brand Name: INEB
• Type of Device: NEBULIZER
• Manufacturer (Section D): PHILIPS RESPIRONICS / RESPIRONICS RESPIRATORY DRUG DELIVERY (UK) LTD.
• MDR Report Key: 7742940
• MDR Text Key: 115966973
• Report Number: MW5078809
• 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: Pharmacist
• Type of Report: Initial
• Report Date: 07/17/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/01/2018
• 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
• Patient Age: 76 YR