BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VS NEWBORN HEART RATE MONITOR

    MDR report key: 20863022 · Received December 6, 2024

    Report

    Report Number
    3018685978-2024-00002
    Event Type
    Malfunction
    Date Received
    December 6, 2024
    Date of Event
    January 4, 2023
    Report Date
    January 4, 2023
    Manufacturer
    SUREPULSE MEDICAL LIMITED
    Product Code
    DQA
    PMA / PMN Number
    K201887
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    NURSE
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE LABELLING ARTWORK WAS SIGNED OFF IN FEBRUARY 2022 BEFORE BEING SENT TO CAPATEX LTD FOR USE IN PRODUCTION. THE TYPOGRAPHICAL ERROR WAS MISSED DURING THE SIGN OFF. THERE WERE NO CHANGES TO THE SIZE GUIDE PART OF THE LABEL INTENDED TO BE MADE AND THE SIGN OFFS WERE RELATED TO A REDESIGN TO INCORPORATE THE DEVICE UDI INTO THE ARTWORK. HOWEVER UPON INVESTIGATION IT WAS REVEALED THAT THE LABEL HAD TO BE REDRAWN TO ACCOMODATE THIS CHANGE, AND THEREFORE THE SIGN OFF MISSED THE RELAYOUT OF THE SIZE GUIDE. THE FOLLOWING CORRECTIONS AND CORRECTIVE ACTIONS WERE UNDERTAKEN: ARTWORK WAS CORRECTED AT SOURCE. AN ADVISORY NOTICE WAS ISSUED TO AFFECTED USER FACILITIES. ALL OTHER ARTWORK RELATING TO THE MEDICAL DEVICE WAS INSPECTED TO ENSURE THAT THIS WAS NOT A SYSTEMATIC ISSUE.

    Description of Event or Problem · 0

    A USER FACILITY REPORTED THAT THE BAG (PRIMARY PACKAGING) THE VS CAP IS PACKAGED IN HAS A TYPOGRAPHICAL ERROR ON THE LABEL. IN THE SIZING CHART THE EXTRA LARGE CAPS HAVE A SIZE OF '24 TO 40CM' THIS SHOULD READ '34 TO 40CM'. THIS ARTWORK ISSUE AFFECTS ALL 5 VS CAP SIZES AS THIS PART OF THE ARTWORK REMAINS THE SAME REGARDLESS OF SIZE CONTAINED WITHIN THE BAG. THE AFFECTED BATCHES ARE LISTED BELOW: 13826/00001, 13821/00001, 13831/00001, 13836/00001, 13837/00001, 13832/00001, 13827/00001, 13817/00001, 13822/00001, 13838/00001, 13833/00001, 13829/00001, 13819/00001, 13839/00001, 13834/00001, 13816/00001.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2121390 VS NEWBORN HEART RATE MONITOR HEART RATE MONITOR DQA SUREPULSE MEDICAL LIMITED 13838/00001

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown