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

Model Number 1025DS

Device Problem Mechanical Problem (1384)

Patient Problem Low Oxygen Saturation (2477)

Event Date 01/17/2024

Event Type  Injury  

Event Description

Devilbiss healthcare was notified by a provider that moments after a humidifier bottle was installed on an oxygen concentrator, the concentrator visually alarmed and became extremely hot.The end user reportedly became cyanotic after 5 minutes of no oxygen, and was taken to the hospital.The end user refuses to provide information on any medical intervention received at the hospitalization.Drive devilbiss healthcare is currently investigating the incident.An update will be filed if additional information becomes available.

Manufacturer Narrative

Devilbiss healthcare previously reported that moments after a humidifier bottle was installed on an oxygen concentrator, the concentrator visually alarmed and became extremely hot.The end user reportedly became cyanotic after 5 minutes of no oxygen, and was taken to the hospital.The end user refuses to provide information on any medical intervention received at the hospitalization.The device was returned for evaluation.There was no warping of the device enclosure, or any other evidence of overheating or high gas temperature errors.Separately, it was noted that the board was slow to start up, and that there was evidence of sieve damage, which caused the device to have low oxygen concentration.The device was repaired and meets all specifications.

• Brand Name: DEVILBISS HEALTHCARE
• Type of Device: GENERATOR, OXYGEN, PORTABLE
• Manufacturer (Section D): DEVILBISS HEALTHCARE; 100 devilbiss drive; somerset PA 15501
• Manufacturer (Section G): DEVILBISS HEALTHCARE; 100 devilbiss drive; somerset PA 15501
• Manufacturer Contact: jess bohrer ; 100 devilbiss drive; somerset, PA 15501
• MDR Report Key: 18726436
• MDR Text Key: 335691436
• Report Number: 2515872-2024-00008
• Device Sequence Number: 1
• Product Code: CAW
• 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: User Facility
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 02/16/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/16/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: 1025DS
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/08/2024
• Date Manufacturer Received: 01/17/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/20/2022
• 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