BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PAD CONNECTOR CABLE

    MDR report key: 3906341 · Received June 5, 2014

    Report

    Report Number
    1218950-2014-03176
    Event Type
    Malfunction
    Date Received
    June 5, 2014
    Report Date
    May 16, 2014
    Manufacturer
    PHILIPS MEDICAL SYSTEMS
    Product Code
    MJK
    PMA / PMN Number
    K992453
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    HK
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). A FOLLOW UP REPORT WILL BE SUBMITTED UPON COMPLETION OF THE INVESTIGATION.

    Description of Event or Problem · 1

    IT WAS REPORTED TO PHILIPS HEALTHCARE THAT THE PADS CABLE WAS DEFECTIVE. THERE WAS NO PT INVOLVEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    330376 PAD CONNECTOR CABLE MJK PHILIPS MEDICAL SYSTEMS M3508A

    Patients

    Seq Age Sex Outcome Treatment
    1