BEUDAMED
    FDA Adverse Event Other Summary report: N

    HEARTSTART MRX

    MDR report key: 2253134 · Received July 26, 2011

    Report

    Report Number
    1218950-2011-02141
    Event Type
    Other
    Date Received
    July 26, 2011
    Report Date
    June 28, 2011
    Manufacturer
    PHILIPS HEALTHCARE - ANDOVER
    Product Code
    MKJ
    PMA / PMN Number
    K031187
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE CUSTOMER REPORTED MULTIPLE OPERATIONAL CHECK ERRORS AND THAT THE KNOB FAILED TO POWER THE DEVICE OFF. THE DEVICE WAS EVALUATED AT PHILIPS. THE SYMPTOM WAS VERIFIED/CLARIFIED AS THE DEVICE WOULD LOCK UP DURING OPCHECK. THE ISSUE WAS LOCALIZED TO CORRUPT SOFTWARE. THE SOFTWARE WAS RELOADED TO RESOLVE THE ISSUE.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED MULTIPLE OPCHECK ERRORS AND THAT THE KNOB FAILED TO POWER THE DEVICE OFF.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HEARTSTART MRX MKJ PHILIPS HEALTHCARE - ANDOVER M3535A

    Patients

    Seq Age Sex Outcome Treatment
    1