MAUDE Adverse Event Report: CAIRE, INC. CAIRE FREESTYLE PORTABLE OXYGEN CONCENTRATOR; GENERATOR, OXYGEN, PORTABLE

Device Problem Product Quality Problem (1506)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 10/24/2022

Event Type  Injury  

Event Description

Reoccurring issue with constant blowing of fuses both in car and in units power cord.Caire freestyle comfort portable oxygen concentrator.We have replaced fuses in my 2017 dodge 4x on the date above there was a audible pop and it blew out a good portion of my vehicles electrical dash lighting.Currently awaiting to get it in for service.This is a new unit and was replaced by my supplier multiple times for similar issues.Home power brick heats up to temperature that will almost burn you if you pick it up.I am afraid that it will start my home or vehicle, or worse me, on fire.It supplies oxygen and should not be functioning like this.My medical supplier is of no help and reaching out to manufacturer has not been productive.Fda safety report id #(b)(4).

• Brand Name: CAIRE FREESTYLE PORTABLE OXYGEN CONCENTRATOR
• Type of Device: GENERATOR, OXYGEN, PORTABLE
• Manufacturer (Section D): CAIRE, INC.
• MDR Report Key: 15690695
• MDR Text Key: 302724909
• Report Number: MW5112942
• Device Sequence Number: 1
• Product Code: CAW
• Combination Product (y/n): N
• 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: 10/26/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/27/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Was Device Available for Evaluation?: Yes
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 53 YR
• Patient Sex: Female
• Patient Ethnicity: Non Hispanic
• Patient Race: American Indian Or Alaskan Native