MAUDE Adverse Event Report: DEVILBISS HEALTHCARE LLC DEVILBISS HEALTHCARE; VENTILATOR, NON-CONTINUOUS (RESPIRATOR)

Model Number	DV64D-HHPD
Medical Device Problem Code	Contamination (1120)
Health Effect - Clinical Code	Respiratory Tract Infection (2420)
Date of Event	01/09/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
Devilbiss healthcare was notified of a complaint involving an intellipap2 auto cpap device, which the end-user stated, "my intellipap2 has been malfunctioning for several weeks.Yesterday, it exploded black stuff all through the machine." the end user stated she has "respiratory issues, sinus infections and congestion." the end-user also stated that she "was prescribed antibiotics and a steroid inhaler." the end-user indicated that she received the device in 2016, and the serial number confirms the device is 8 years old, which is 3 years beyond the device's expected service life.This model auto cpap does not contain black foam or pe-pur foam.Devilbiss is currently investigating the incident, including attempting to retrieve the device to perform a comprehensive investigation.An update will be filed if additional information becomes available.

• Brand Name: DEVILBISS HEALTHCARE
• Common Device Name: VENTILATOR, NON-CONTINUOUS (RESPIRATOR)
• 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: jess bohrer ; 100 devilbiss drive; somerset, PA 15501
• MDR Report Key: 18546452
• Report Number: 2515872-2024-00001
• Device Sequence Number: 8915005
• Product Code: BZD
• UDI-Device Identifier: 00885304009269
• UDI-Public: 885304009269
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K112220
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Consumer
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 01/19/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Lay User/Patient
• Device Model Number: DV64D-HHPD
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/11/2024
• Initial Report FDA Received Date: 01/19/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 02/16/2016
• 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
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Female