MAUDE Adverse Event Report: OXYGOFIT; GENERATOR, OXYGEN, PORTABLE

Model Number 1400-2000

Device Problems Failure to Power Up (1476); Therapeutic or Diagnostic Output Failure (3023)

Patient Problems Dyspnea (1816); Dizziness (2194)

Event Date 11/23/2020

Event Type  malfunction  

Event Description

When device stopped working i become very dyspneic and lightheaded with an sao2 of 83%.In several occasions the oxygen concentrator stopped working and would not restart for over an hour.On the most recent i was walking about a mile from my home and the device stopped and would restart for about 30 second then eventually would not restart.Applied home healthcare equipment.

• Brand Name: OXYGOFIT
• Type of Device: GENERATOR, OXYGEN, PORTABLE
• MDR Report Key: 10940209
• MDR Text Key: 219528517
• Report Number: MW5098188
• Device Sequence Number: 1
• Product Code: CAW
• Combination Product (y/n): Y
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Patient
• Type of Report: Initial
• Report Date: 12/02/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/02/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: 1400-2000
• Was Device Available for Evaluation?: No
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 72 YR
• Patient Weight: 91