BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HEARTSTART MRX

    MDR report key: 3040463 · Received February 7, 2013

    Report

    Report Number
    1218950-2013-00446
    Event Type
    Malfunction
    Date Received
    February 7, 2013
    Report Date
    January 16, 2013
    Manufacturer
    PHILIPS MEDICAL SYSTEMS
    Product Code
    MKJ
    PMA / PMN Number
    K031187
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE CUSTOMER REPORTED A RED X WHEN THEY WENT TO USE THE DEVICE IN A CARDIAC ARREST. THERE WAS NO NEGATIVE IMPACT AS THE USERS HAD A SECOND DEFIBRILLATOR AVAILABLE FOR USE. THE COMPLAINT IS STILL BEING INVESTIGATED. A FOLLOW-UP REPORT WILL BE SUBMITTED UPON COMPLETION OF THE INVESTIGATION.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED A RED X WHEN THEY WENT TO USE THE DEVICE IN A CARDIAC ARREST. THERE WAS NO NEGATIVE IMPACT AS THE USERS HAD A SECOND DEFIBRILLATOR AVAILABLE FOR USE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    53247 HEARTSTART MRX MKJ PHILIPS MEDICAL SYSTEMS M3535A

    Patients

    Seq Age Sex Outcome Treatment
    1