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

Model Number	306DS
Medical Device Problem Code	Melted (1385)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Event or Problem Description
Devilbiss healthcare was notified by a home oxygen provider of a complaint involving a portable oxygen concentrator.The provider stated, "while in use, the charger that plugs into dc outlet melted, causing the unit to break." there was no report or evidence of illness, injury or medical treatment associated with the complaint.The portable concentrator and power supply are being returned to devilbiss for evaluation.An update will be filed if new information becomes available.

• 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.; port washington, NY 11050 ; 5169984600
• MDR Report Key: 15337172
• Report Number: 2515872-2022-00047
• Device Sequence Number: 17897567
• Product Code: CAW
• UDI-Device Identifier: 00885304002277
• UDI-Public: 885304002277
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• PMA/510(K) Number: K081468
• 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): 09/01/2022

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: 306DS
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/20/2022
• Initial Report FDA Received Date: 09/01/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 01/10/2022
• 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