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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DEVILBISS HEALTHCARE LLC DEVILBISS INTELLIPAP UNIT

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DEVILBISS HEALTHCARE LLC DEVILBISS INTELLIPAP UNIT Back to Search Results
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".
 
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Brand NameDEVILBISS
Type of DeviceINTELLIPAP 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 Key7237597
MDR Text Key99775543
Report Number2515872-2018-00002
Device Sequence Number1
Product Code LEL
Combination Product (y/n)N
Reporter Country CodeUK
PMA/PMN Number
K112220
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type distributor,foreign
Reporter Occupation
Type of Report Initial
Report Date 12/01/2017
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received02/02/2018
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberDV54UK-P
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer12/12/2017
Is the Reporter a Health Professional? No
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received12/01/2017
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured02/04/2016
Is the Device Single Use? No Answer Provided
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage

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