MAUDE Adverse Event Report: O2 CONCEPTS PORTABLE OXYGEN CONCENTRATOR; PORTABLE OXYGEN CONCENTRATOR

Model Number INDEPENDENCE

Device Problems Charging Problem (2892); No Flow (2991)

Patient Problem Dyspnea (1816)

Event Date 12/11/2016

Event Type  Other  

Event Description

A supplier of an fda approved portable oxygen concentrator (poc), (b)(4), knowingly disregarded faa regulations and good medicine and switched their previous approval to board and said poc.Resulting in pt running out of oxygen mid-flight, requiring the use of emergency medical supplies and support onboard.Pt had to stay overnight in (b)(6) to reacquire enough battery to continue on their transit.Putting pt and entire aircraft at risk.(b)(4) is the supplier of this device to the pt.They know the requirements and needs of the device, pt, and faa/dot regulations.

• Brand Name: PORTABLE OXYGEN CONCENTRATOR
• Type of Device: PORTABLE OXYGEN CONCENTRATOR
• Manufacturer (Section D): O2 CONCEPTS; 6303 waterford blvd; #150; OK 73118
• MDR Report Key: 6185654
• MDR Text Key: 63133896
• Report Number: MW5066767
• Device Sequence Number: 1
• Product Code: CAW
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 12/13/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/13/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: INDEPENDENCE
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other