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

Model Number	535C-D-870
Medical Device Problem Code	Mechanical Problem (1384)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/16/2025
Type of Reportable Event	Malfunction
Event or Problem Description
Devilbiss healthcare was notified of an incident involving an oxygen cylinder by the provider, who reported that while being filled on an ifill device, the cylinder broke apart at the nipple adapter and disconnected.The cylinder, having been under pressure, propelled itself across the room.There was no report or evidence of illness, serious injury or medical treatment associated with the complaint.Devilbiss healthcare will file an update if additional information becomes available.

• Brand Name: DEVILBISS D CYLINDER
• Common Device Name: 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 ; 5169984600
• MDR Report Key: 22470057
• Report Number: 2515872-2025-00022
• Device Sequence Number: 4096890
• Product Code: CAW
• UDI-Device Identifier: 00885304020936
• UDI-Public: (01)00885304020936
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K053240
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,User Facility
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 07/10/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Other
• Device Model Number: 535C-D-870
• Device Catalogue Number: 535C-D-870
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/08/2025
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/16/2025
• Initial Report FDA Received Date: 07/10/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: IFILL OXYGEN STATION SN (B)(6).
• Patient Sex: Unknown