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

Model Number DV64D-HHPD

Device Problem Contamination (1120)

Patient Problem Respiratory Tract Infection (2420)

Event Date 01/09/2024

Event Type  Injury  

Event 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
• Type of Device: 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
• MDR Text Key: 333280030
• Report Number: 2515872-2024-00001
• Device Sequence Number: 1
• Product Code: BZD
• UDI-Device Identifier: 00885304009269
• UDI-Public: 885304009269
• Combination Product (y/n): N
• Reporter Country Code: CA
• PMA/PMN Number: K112220
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Consumer
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 01/19/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/19/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: DV64D-HHPD
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 01/11/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/16/2016
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Sex: Female