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

Model Number	DV5
Medical Device Problem Code	Thermal Decomposition of Device (1071)
Health Effect - Clinical Code	No Information (3190)
Date of Event	11/08/2017
Type of Reportable Event	Malfunction
Additional 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 distributor suggested the root cause was "tracking phenomenon, mainly caused by dust and humidity residue in the plug allowing small electrical current to flow and cause it to ignite." however, the distributor did not provide any details or objective evidence of their root cause investigation and analysis to support their hypothesis.Devilbiss healthcare has requested the results of the distributor's root cause analysis and/or investigation on several occasions, but to date this has not been received.A devilbiss healthcare engineering evaluation suggests there may be a failure that was initiated by arcing between the line cord receptacle and pin in the ac input module.The evidence suggests this was caused by a partial engagement of the line cord to the ac input module or otherwise stated, the line cord was not fully and properly plugged in.This issue might be exacerbated by the presence of dust and humidity residue at the point of the ac connection.It is important to note, the devilbiss intellipap model dv53 series standard plus cpap, instructions for use, states on page 6, the patient must "fully insert the power cord into the back of the device and plug the other end of the power cord into a power wall unit.".
Event or Problem Description
As indicated in an email communication from (b)(4) (devilbiss healthcare's (b)(4) distributor), a customer returned a devilbiss manufactured cpap product: "cpap intellipap, model dv53" asserting the device had "burned." upon our request, the distributor provided photographs of the device, which indicated the location of the burned area, which appeared to be at the ac power supply input.The distributor ((b)(4)) also stated there was no report of injury associated with this incident.

• Brand Name: DEVILBISS
• Common Device Name: INTELLIPAP UNIT
• Manufacturer (Section D): DEVILBISS HEALTHCARE LLC; 100 devilbiss drive; somerset PA 15501
• MDR Report Key: 7237577
• Report Number: 2515872-2018-00001
• Device Sequence Number: 1146103
• Product Code: BZD
• UDI-Device Identifier: 00885304006862
• UDI-Public: 00885304006862
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K112220
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor,foreign
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 11/08/2017

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: DV5
• Device Catalogue Number: DV53
• Device Lot Number: N/A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/04/2018
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 11/08/2017
• Initial Report FDA Received Date: 02/02/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 56 YR
• Patient Weight: 87