MAUDE Adverse Event Report: DEVILBISS HEALTHCARE DEVILBISS; CPAP

Model Number	DV55D-HH
Medical Device Problem Code	Device Emits Odor (1425)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/15/2021
Type of Reportable Event	Malfunction
Event or Problem Description
Devilbiss healthcare is the manufacturer of the device which is a portable oxygen concentrator.We are awaiting return of the device for evaluation we are filing this report in an overabundance of caution to be timely.A follow-up submission will be filed when additional data becomes available.While in normal use the device made a noise and began emitting a burning smell.The user's wife woke him up.There was no patient consequence.The device is out of warranty on july 6, 2021.

• Brand Name: DEVILBISS
• Common Device Name: CPAP
• Manufacturer (Section D): DEVILBISS HEALTHCARE; 100 devilbiss drive; somerset PA 15501
• MDR Report Key: 12628363
• Report Number: 2515872-2021-00017
• Device Sequence Number: 3651034
• Product Code: BZD
• UDI-Device Identifier: 00885304001973
• UDI-Public: 885304001973
• Combination Product (Y/N): N
• Initial Reporter State: MN
• Initial Reporter Country: US
• PMA/510(K) Number: K091919
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: consumer
• Initial Reporter Occupation: Other
• Remedial Action: Inspection
• Type of Report: Initial
• Report Date (Section B): 10/13/2021

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: Lay User/Patient
• Device Model Number: DV55D-HH
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/28/2021
• Initial Report FDA Received Date: 10/13/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1