BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HEARTSTART MRX

    MDR report key: 3071171 · Received April 8, 2013

    Report

    Report Number
    1218950-2013-01280
    Event Type
    Malfunction
    Date Received
    April 8, 2013
    Report Date
    March 14, 2013
    Manufacturer
    PHILIPS MEDICAL SYSTEMS
    Product Code
    MKJ
    PMA / PMN Number
    K031187
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OK, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE CUSTOMER REPORTED THAT THE DEVICE DISPLAYED A RED X ON THE READY FOR USE INDICATOR AND INTERMITTENTLY FAILED TO POWER UP. THERE WAS NO REPORTED PT INVOLVEMENT. THE COMPLAINT IS STILL UNDER INVESTIGATION. A F/U REPORT WILL BE SUBMITTED UPON COMPLETION OF THE INVESTIGATION.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT THE DEVICE DISPLAYED A RED X ON THE READY FOR USE INDICATOR AND INTERMITTENTLY FAILED TO POWER UP. THERE WAS NO REPORTED PT INVOLVEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    142878 HEARTSTART MRX MKJ PHILIPS MEDICAL SYSTEMS M3535A

    Patients

    Seq Age Sex Outcome Treatment
    1