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

Device Problem Device Contamination with Chemical or Other Material (2944)

Patient Problem Insufficient Information (4580)

Event Date 07/01/2019

Event Type  Injury  

Event Description

Oxygen concentrator and filter provided by preferred homehealth care and needed regularly scheduled maintenance.This has not been done in two years and i have discovered two separate filters with black mold in them.This leads me to believe i have been inhaling black mold spores and have been experienced unexplained sickness relayed to this incident.Preferred healthcare.Fda safety report id# (b)(4).

• Brand Name: OXYGEN CONCENTRATOR
• Type of Device: GENERATOR, OXYGEN, PORTABLE
• MDR Report Key: 12697353
• MDR Text Key: 278609402
• Report Number: MW5104950
• Device Sequence Number: 1
• Product Code: CAW
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Type of Report: Initial
• Report Date: 10/21/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/25/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Was Device Available for Evaluation?: Yes
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention; Disability
• Patient Age: 73 YR
• Patient Weight: 66