MAUDE Adverse Event Report: DEVILBISS HEALTHCARE LLC DEVILBISS; INTELLIPAP

Model Number DV5

Device Problem Thermal Decomposition of Device (1071)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 01/01/2018

Event Type  malfunction  

Manufacturer Narrative

The devilbiss intellipap model dv53 series standard plus cpap intended use is in the treatment of obstructive sleep apnea syndrome (osa) in spontaneously breathing patients (b)(6) and above by means of application of positive air pressure.The device is intended to be used in home and clinical environments.The cpap model dv54ne-p was evaluated by our engineering department.The investigation reveals evidence of a thermal event that was traced to the oxygen inlet port adapter, which was located at the humidifier flow outlet between the outlet and the cpap supply tubing.The thermal damage patterns indicate the oxygen was flowing into the cpap while the cpap blower was not operating (oxygen flowing into the unit from the gas source but the cpap device was not turned on).Allowing oxygen to flow into the cpap unit that is not operating is contraindicated, as noted in the dv54ne-p user manual se-dv53-2 rev a in the section "warning- oxygen use", which provides clear warning of the danger and risk of fire associated with oxygen flowing into the cpap without the blower operating.The investigation and findings indicate that user did not follow the instructions in the product's user manual.

Event Description

As communicated in an email to devilbiss from our ec representative, the distributor based in (b)(6) ((b)(4)) advised about an event associated with a cpap sleepcube, model dv54ne-p.The distributor communicated the following information: "event location: living room the patient in (b)(6).Event description: the device was connected to the power line and the customer left the room in which the device was located.Shortly thereafter, the smoke alarm sounded and the appliance burned according to the message on (or near) the air outlet of the humidifier." in a subsequent communication with the distributor, it was confirmed that the cpap unit was connected to an oxygen source; and "there was no injury on the patient and may have been a wrong intend of usage." it was also confirmed the device was not being used for treatment and/or for diagnosis when the incident happened.

• Brand Name: DEVILBISS
• Type of Device: 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: figueroa ; 100 devilbiss drive; somerset, PA 15501 ; 8003381988
• MDR Report Key: 7310969
• MDR Text Key: 101699887
• Report Number: 2515872-2018-00004
• Device Sequence Number: 1
• Product Code: LEL
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: K112220
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,foreign
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 02/02/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/02/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: DV5
• Device Catalogue Number: DV54NE-P
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/13/2018
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 02/02/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/28/2012
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 84 YR
• Patient Weight: 86