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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DEVILBISS HEALTHCARE, LLC DEVILBISS CPAP

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DEVILBISS HEALTHCARE, LLC DEVILBISS CPAP Back to Search Results
Model Number DV51UK
Device Problem Arcing (2583)
Patient Problem No Information (3190)
Event Date 06/08/2016
Event Type  malfunction  
Manufacturer Narrative
The incident was reported to devilbiss healthcare's (b)(4) distributor of the device who stated there was "damage to the connection of the (j8) ac voltage power connector to printed circuit board (pcb)". The (b)(4) distributor noted that the (j8) ac voltage power connector was arcing and that it was cold soldered to the printed circuit board (pcb) board. The (b)(4) distributor reported there appeared to be damage to the solder joint and the damage was more than likely caused by excessive force or mechanical stress applied to the connector. The unit was returned to devilbiss healthcare and an engineering inspection and evaluation was performed, which confirmed that the cpap unit had a cold solder joint between the printed circuit board (pcb) and the (j8) ac voltage power connector. The cold solder joint was the result of improper welding technique during the electronic assembly process of the printed circuit board (pcb). This is localized to the position on the board and internal to the device. Devilbiss healthcare has notified the printed circuit board (pcb) manufacturer.
 
Event Description
The devilbiss healthcare's (b)(4) distributor reported the cpap dv51uk,'s (j8) ac voltage power connector soldered to the internal printed circuit board (pcb) was arcing. The (b)(4) distributor reported there was no patient harm.
 
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Brand NameDEVILBISS
Type of DeviceCPAP
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 Key7237591
MDR Text Key99089617
Report Number2515872-2018-00003
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 12/18/2017
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 NumberDV51UK
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer11/27/2017
Is the Reporter a Health Professional? No
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received01/25/2017
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured12/01/2014
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unkown

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