BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DEVILBISS

    MDR report key: 7237591 · Received February 2, 2018

    Report

    Report Number
    2515872-2018-00003
    Event Type
    Malfunction
    Date Received
    February 2, 2018
    Date of Event
    June 8, 2016
    Report Date
    December 18, 2017
    Manufacturer
    DEVILBISS HEALTHCARE, LLC
    Product Code
    LEL
    UDI-DI
    00885304002017
    PMA / PMN Number
    K112220
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    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.

    Description of Event or Problem · 1

    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.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    80393 DEVILBISS CPAP LEL DEVILBISS HEALTHCARE, LLC DV51UK 00885304002017

    Patients

    Seq Age Sex Outcome Treatment
    1