MAUDE Adverse Event Report: DEVILBISS HEALTHCARE LLC DEVILBISS; OXYGEN CONCENTRATOR

Model Number	525DS-Q
Medical Device Problem Code	No Flow (2991)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/02/2022
Type of Reportable Event	Malfunction
Event or Problem Description
Devilbiss healthcare was notified by an authorized service center of a complaint involving an oxygen concentrator with a complaint of "no o2 at all." there was no report or evidence of illness, injury or medical treatment associated with the complaint.The root cause of the no o2 is shipping damage which caused the tubing to become disconnected from the flow meter.

• Brand Name: DEVILBISS
• Common Device Name: OXYGEN CONCENTRATOR
• 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: jillian forster ; 99 seaview blvd; ste 210; port washington, NY 11050 ; 5169984600
• MDR Report Key: 15361622
• Report Number: 2515872-2022-00206
• Device Sequence Number: 6023307
• Product Code: CAW
• UDI-Device Identifier: 00885304009689
• UDI-Public: 885304009689
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K071397
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Distributor
• Initial Reporter Occupation: Other
• Remedial Action: Replace
• Type of Report: Initial
• Report Date (Section B): 09/06/2022

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
• Device Model Number: 525DS-Q
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/31/2022
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/02/2022
• Initial Report FDA Received Date: 09/06/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/08/2022
• 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
• Patient Sex: Unknown