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

Model Number 525DS

Device Problem Mechanical Problem (1384)

Patient Problems Dyspnea (1816); Pneumonia (2011)

Event Date 02/26/2024

Event Type  Injury  

Event Description

Devilbiss healthcare was notified of an incident involving an oxygen concentrator by the end user's nephew, who stated the device was not producing oxygen, but was reportedly alarming as intended.The end user's nephew indicated that his uncle was having trouble breathing or could not breathe, and was taken to the hospital where he was diagnosed with pneumonia.It is unknown whether the end user suffered any injury associated with the device's failure to produce oxygen.The nephew stated that he returned the device to the provider, but could not provide the name of the provider or any identifying information on the concentrator.Devilbiss will file an update will be filed if additional information becomes available.

• Brand Name: DEVILBISS HEALTHCARE
• Type of Device: GENERATOR, OXYGEN, PORTABLE
• Manufacturer (Section D): DEVILBISS HEALTHCARE LLC; 100 devilbiss drive; somerset PA 15501
• Manufacturer (Section G): DEVILBISS HEALTHCARE LLC; 100 devilbiss drive; somerset PA 15501
• Manufacturer Contact: jess bohrer ; 100 devilbiss drive; somerset, PA 15501
• MDR Report Key: 18944491
• MDR Text Key: 338184398
• Report Number: 2515872-2024-00015
• Device Sequence Number: 1
• Product Code: CAW
• UDI-Device Identifier: 00885304000846
• UDI-Public: 885304000846
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K071397
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 03/20/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/20/2024
• 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: 02/26/2024
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 02/20/2023
• Is the Device Single Use?: No
• 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: Male