BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HEARTSMART MRX

    MDR report key: 1852784 · Received September 25, 2010

    Report

    Report Number
    1218950-2010-01721
    Event Type
    Malfunction
    Date Received
    September 25, 2010
    Report Date
    June 29, 2010
    Product Code
    MKJ
    PMA / PMN Number
    K031187
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE CUSTOMER REPORTED THAT THE DEVICE WAS NOT DETECTING THE TEST LOAD. THE CUSTOMER LOCALIZED THE ISSUE TO A FAILED PADS CABLE. REPLACING THE PADS CABLE RESOLVED THE ISSUE.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT THE DEVICE WAS NOT DETECTING THE TEST LOAD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HEARTSMART MRX MKJ M3535A

    Patients

    Seq Age Sex Outcome Treatment
    1