MAUDE Adverse Event Report: DEVILBISS HEALTHCARE LLC DEVILBISS HEALTHCARE; INTELLIPAP

Model Number	DV54D-HH
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/04/2022
Type of Reportable Event	Malfunction
Event or Problem Description
On april 13, 2022, devilbiss was notified of a complaint involving devilbiss dv54 intellipap autoadjust¿ cpap device by a distributor.The distributor was contacted by the end user, who reported that all of a sudden, after using the device overnight, he "woke up with a nose full of black snow." the device is 13.5 years old, and the end user reported that "during the 13 years he has owned" the device, "he had not noticed anything abnormal before this event occurred." the end user did not report any injury or illness associated with the event.The end user reported that he "went to the doctor, who referred him to a pulmonologist, who advised him to stop using the machine." the distributor requested the end user return the device for evaluation, which the patient refused to do, so it is currently unclear as to what would cause anything that could be described as "black snow" to come out of the device all of a sudden after 13.5 years of normal operation.Devilbiss is actively working with the distributor to seek permission to contact the end user directly to gather more information and retrieve the unit for a comprehensive evaluation and investigation.

• Brand Name: DEVILBISS HEALTHCARE
• Common Device Name: INTELLIPAP
• 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: lenora patrick ; 99 seaview blvd; port washington, NY 11050 ; 5169984600
• MDR Report Key: 14335574
• Report Number: 2515872-2022-00063
• Device Sequence Number: 6200273
• Product Code: BZD
• UDI-Device Identifier: 00885304001966
• UDI-Public: 00885304001966
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K071689
• 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
• Type of Report: Initial
• Report Date (Section B): 05/02/2022

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
• Operator of Device: Lay User/Patient
• Device Model Number: DV54D-HH
• Device Catalogue Number: DV54D-HH
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 05/09/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 10/06/2008
• 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: Male