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

Model Number DV54UK-P

Device Problem Smoking (1585)

Patient Problem Irritation (1941)

Event Date 11/21/2017

Event Type  malfunction  

Manufacturer Narrative

The devilbiss healthcare's (b)(4) distributor reported that a cpap unit, model dv54uk-p serial (b)(4), with heater model dv5hh serial (b)(4), and smartlink model sv5m serial (b)(4) were returned by the patient.The (b)(4) distributor initially reported that patient's cpap "began to smoke in the night and [smoke] came through the mask." however, upon further communication between (b)(4) distributor and the patient, it was determined the unit stopped operating once the smoke started and the patient had no complaint of injury or health-related issues due to the incident.The unit was returned to devilbiss healthcare and an engineering inspection and evaluation was performed.The results of that investigation indicated that the cpap unit failure was caused by a liquid substance onto/ into the electronic assembly.The unit was in use for about 12 months and the liquid substance on the electronic assembly was likely caused by a spill when in use.

Event Description

Devilbiss healthcare's (b)(4) distributor reported a cpap unit, model dv54uk-p, malfunctioned and "caused minor respiratory irritation to the patient".Patient arrived at the hospital with his cpap unit but there was no indication of the patient was admitted to the hospital.The (b)(6) distributor stated the patient reported "the cpap unit had stopped functioning and smoke started to come out through the mask.It was at this point the cpap device stopped working".

• Brand Name: DEVILBISS
• Type of Device: INTELLIPAP 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: figueroa ; 100 devilbiss drive; somerset, PA 15501 ; 8003381988
• MDR Report Key: 7237597
• MDR Text Key: 99775543
• Report Number: 2515872-2018-00002
• Device Sequence Number: 1
• Product Code: LEL
• UDI-Device Identifier: 00885304000051
• UDI-Public: 00885304000051
• Combination Product (y/n): N
• Reporter Country Code: UK
• 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: 12/01/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/02/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: DV54UK-P
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/12/2017
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 12/01/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/04/2016
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 30 YR