BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HEARTSTART MRX EMS DEFIBRILLATOR

    MDR report key: 3063331 · Received March 27, 2013

    Report

    Report Number
    1218950-2013-01047
    Event Type
    Malfunction
    Date Received
    March 27, 2013
    Report Date
    February 28, 2013
    Manufacturer
    PHILIPS MEDICAL SYSTEMS
    Product Code
    MKJ
    PMA / PMN Number
    K031187
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SF
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4): THE CUSTOMER REPORTED THAT THE PADDLE ASSEMBLY WAS NOT WORKING. THERE WAS NO REPORTED PT INVOLVEMENT. THE COMPLAINT IS STILL BEING INVESTIGATED. A F/U REPORT WILL BE SUBMITTED UPON COMPLETION OF THE INVESTIGATION.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT THE PADDLE ASSEMBLY WAS NOT WORKING. THERE WAS NO REPORTED PT INVOLVEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    126892 HEARTSTART MRX EMS DEFIBRILLATOR MKJ PHILIPS MEDICAL SYSTEMS M3536A

    Patients

    Seq Age Sex Outcome Treatment
    1