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

Model Number	DV51UK
Medical Device Problem Code	Arcing (2583)
Health Effect - Clinical Code	No Information (3190)
Date of Event	06/08/2016
Type of Reportable Event	Malfunction
Additional 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 or Problem 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
• Common Device Name: CPAP
• Manufacturer (Section D): DEVILBISS HEALTHCARE, LLC; 100 devilbiss drive; somerset PA 15501
• MDR Report Key: 7237591
• Report Number: 2515872-2018-00003
• Device Sequence Number: 980663
• Product Code: LEL
• UDI-Device Identifier: 00885304002017
• UDI-Public: 00885304002017
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• 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): 12/18/2017

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: Physician
• Device Model Number: DV51UK
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/27/2017
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 01/25/2017
• 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