BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HEARTSTART MRX

    MDR report key: 3043403 · Received March 11, 2013

    Report

    Report Number
    1218950-2013-00821
    Event Type
    Malfunction
    Date Received
    March 11, 2013
    Report Date
    February 18, 2013
    Manufacturer
    PHILIPS MEDICAL SYSTEMS
    Product Code
    MKJ
    PMA / PMN Number
    K031187
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). A PART QUOTE WAS REQUESTED. THE AVAILABLE INFORMATION INDICATES THAT THE PADDLE SET WAS SUBSEQUENTLY REPLACED. NO ADDITIONAL INFORMATION WAS PROVIDED. THIS COMPLAINT IS STILL BEING INVESTIGATED. A FOLLOW-UP REPORT WILL BE SUBMITTED UPON COMPLETION OF THE INVESTIGATION.

    Description of Event or Problem · 1

    A PART QUOTE WAS REQUESTED. THE AVAILABLE INFORMATION INDICATES THAT THE PADDLE SET WAS SUBSEQUENTLY REPLACED. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    102692 HEARTSTART MRX MKJ PHILIPS MEDICAL SYSTEMS M3535A

    Patients

    Seq Age Sex Outcome Treatment
    1