MAUDE Adverse Event Report: DICKSON ASIA GROUP/VEGA TECHNOLOGIES NEB-PORT; NEBULIZER, DIRECT PATIENT INTERFACE

Model Number NEB-PORT

Device Problem Device Inoperable (1663)

Patient Problems Pneumonia (2011); Missed Dose (2561)

Event Date 03/09/2015

Event Type  Injury  

Manufacturer Narrative

Resubmitting this mdr that was originally submitted on (b)(6) 2015, as i inadvertently submitted it via our test gateway account, instead of the production gateway account.

Event Description

End user's mother called saying the 2nd replacement we sent her wasn't working, same as the 1st one, doesn't power on.A few days after she received it and it stopped working her child got pneumonia and had to go into the hospital.

• Brand Name: NEB-PORT
• Type of Device: NEBULIZER, DIRECT PATIENT INTERFACE
• Manufacturer (Section D): DICKSON ASIA GROUP/VEGA TECHNOLOGIES; yangwu district; dalang town, dongguan; guangdong, guangdong 52378 9; CH 523789
• MDR Report Key: 5098832
• MDR Text Key: 26594579
• Report Number: 3005182235-2015-00007
• Device Sequence Number: 1
• Product Code: CAF
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Distributor
• Reporter Occupation: Medical Equipment Company Technician/Representative
• Report Date: 08/21/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/23/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Patient Family Member or Friend
• Device Model Number: NEB-PORT
• Device Catalogue Number: NEB-PORT
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 08/21/2015
• Distributor Facility Aware Date: 03/11/2015
• Device Age: 2 MO
• Event Location: Home
• Date Report to Manufacturer: 08/21/2015
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization