BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EARLYVUE VS30 VITAL SIGNS MONITOR

    MDR report key: 15139935 · Received August 1, 2022

    Report

    Report Number
    1218950-2022-00664
    Event Type
    Malfunction
    Date Received
    August 1, 2022
    Date of Event
    July 19, 2022
    Manufacturer
    PHILIPS NORTH AMERICA LLC
    Product Code
    DSJ
    UDI-DI
    00884838091412
    PMA / PMN Number
    K190624
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    BIOMEDICAL ENGINEER
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    A FOLLOW-UP REPORT WILL BE SUBMITTED UPON COMPLETION OF THE INVESTIGATION.

    Description of Event or Problem · 0

    THE CUSTOMER REPORTED THE DEVICE MAKES SPARKS AT THE LEVEL OF THE SECTOR PLUG. PATIENT INVOLVEMENT IS UNKNOWN. THERE WAS NO REPORTED PATIENT OR USER IMPACT. THE EARLYVUE VS30 VITALS MONITOR (MODEL NUMBER 863359 IS SUBSTANTIALLY SIMILAR TO THE EARLYVUE VS30 VITALS MONITOR (MODEL NUMBER 863380) AND WILL BE REPORTED IN THE UNITED STATES UNDER DEVICE MODEL NUMBER 863380 (CFN/FEI # 1218950; 510K K190624).

    Description of Event or Problem · 0

    THE CUSTOMER REPORTED THAT WHEN CONNECTING THE MAIN POWER CABLE TO THE DEVICE, THE DEVICE CREATES A SPARK AT THE SECTOR PLUG. THE DEVICE WAS IN USE ON A PATIENT. THERE WAS NO REPORT OF PATIENT OR USER HARM. A PHILIPS FIELD SERVICE ENGINEER (FSE) WENT TO THE CUSTOMER SITE. THE FSE DETERMINED THAT THE POWER MODULE ASSEMBLY REQUIRED REPLACEMENT. THE CHL-VS POWER ENTRY MODULE ASSY, PART NUMBER 453564792341 WAS REPLACED BY THE FSE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2924678 EARLYVUE VS30 VITAL SIGNS MONITOR EARLYVUE VS30 VITAL SIGNS MONITOR DSJ PHILIPS NORTH AMERICA LLC 863380 00884838091412

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown