MAUDE Adverse Event Report: DEVILBISS HEALTHCARE; GENERATOR, OXYGEN, PORTABLE

Model Number 525DS

Device Problem Mechanical Problem (1384)

Patient Problem Low Oxygen Saturation (2477)

Event Date 01/18/2024

Event Type  Injury  

Event Description

Devilbiss healthcare was notified of an incident by the end user's son, who reported that an oxygen concentrator was not working properly because it was not producing oxygen.The end user was admitted to the hospital for lack of oxygen and increased carbon dioxide levels.Devilbiss is currently investigating the incident, including attempting to retrieve the device for investigation.An update will be filed if additional information becomes available.

• Brand Name: DEVILBISS HEALTHCARE
• Type of Device: GENERATOR, OXYGEN, PORTABLE
• MDR Report Key: 18717817
• MDR Text Key: 335524013
• Report Number: 2515872-2024-00009
• Device Sequence Number: 1
• Product Code: CAW
• Combination Product (y/n): N
• PMA/PMN Number: K071397
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other
• Type of Report: Initial
• Report Date: 02/15/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/15/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: 525DS
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 01/18/2024
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 03/21/2023
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization
• Patient Sex: Female