MAUDE Adverse Event Report: DEVILBISS HEALTHCARE LLC DEVILBISS; HOME CPAP UNIT

Model Number	DV51D
Medical Device Problem Codes	Material Discolored (1170); Material Puncture/Hole (1504)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/30/2022
Type of Reportable Event	Malfunction
Event or Problem Description
Devilbiss healthcare was notified via a medwatch report #mw5113485 of a complaint involving a devilbiss cpap machine.The medwatch report was filed by the end-user, who stated "i noted black debris in my cpap hose.I took the machine apart and found a hole was torn [in the foam] near the circulation pump [flow generator]." he also state "the foam insulation turned into a black sticky tar like substance." devilbiss initiated an investigation, including a discussion with the end-user, who claims to have been using the devilbiss cpap for more than 5 years.The serial number of the unit confirms the device was sold 9.5 years ago, which at the time of the incident was nearly twice the 5-year expected service life of the unit.The end-user stated he used the cpap device nightly for approximately 8 hours, and has not experienced any illness or injury relating to this complaint.He also confirmed he stopped using the device since observing the debris in the tubing (he has another device).He noted that approximately three years ago he began cleaning the cpap unit daily with an ozone cleaning device (soclean®) for 12 minutes, and expressed concern the use of the ozone cleaner "may have caused the issue." ozone and ozone cleaning devices are not recommended or approved for use with devilbiss cpap devices.The unit is being returned to devilbiss for evaluation.An update will be filed if new information becomes available.

• Brand Name: DEVILBISS
• Common Device Name: HOME CPAP UNIT
• 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: 16039494
• Report Number: 2515872-2022-00243
• Device Sequence Number: 17512342
• Product Code: BZD
• UDI-Device Identifier: 00885304001843
• UDI-Public: 00885304001843
• Combination Product (Y/N): N
• Initial Reporter State: AZ
• 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: Other
• Initial Reporter Occupation: Other
• Remedial Action: Inspection
• Type of Report: Initial
• Report Date (Section B): 12/22/2022

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: DV51D
• Device Catalogue Number: DV51D
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/02/2022
• Initial Report FDA Received Date: 12/22/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 05/02/2013
• 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: Reuse
• Patient Sequence Number: 1
• Patient Age: 73 YR
• Patient Sex: Male
• Patient Weight: 92 KG