MAUDE Adverse Event Report: DEVILBISS HEALTHCARE, LLC DEVILBISS; CPAP

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.

• Brand Name: DEVILBISS
• Type of Device: CPAP
• 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: 7237591
• MDR Text Key: 99089617
• Report Number: 2515872-2018-00003
• Device Sequence Number: 1
• Product Code: LEL
• UDI-Device Identifier: 00885304002017
• UDI-Public: 00885304002017
• 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: 12/18/2017

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: Physician
• Device Model Number: DV51UK
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/27/2017
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 01/25/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/01/2014
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1