BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HEARTSTART MRX -EMS DEFIBRILLATOR

    MDR report key: 2083155 · Received April 13, 2011

    Report

    Report Number
    1218950-2011-01006
    Event Type
    Malfunction
    Date Received
    April 13, 2011
    Report Date
    March 14, 2011
    Manufacturer
    PHILIPS HEALTHCARE
    Product Code
    MKJ
    PMA / PMN Number
    K031187
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE CUSTOMER REPORTED A RED X AND CHIP AS THE POWER WAS APPLIED. THE SETTINGS ON THE DEVICE KEPT ON RESETTING BACK TO DEFAULT VALUES. THERE WAS NO REPORTED PT INVOLVEMENT. A PHILIPS FIELD SERVICE ENGINEER EVALUATED THE DEVICE AND CONFIRMED THE PROBLEM. A PHILIPS INVESTIGATOR CONTACTED THE FIELD SERVICE ENGINEER FOR FURTHER CLARIFICATION OF THE SYMPTOM. THE FSE STATED THAT THE DEVICE HAD FAILED TO POWER UP. THE FSE STATED THAT THE PROBLEM WAS RESOLVED BY REPLACING THE PROCESSOR PCA.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED A RED X AND CHIP AS THE POWER WAS APPLIED. THE SETTINGS ON THE DEVICE KEPT ON RESETTING BACK TO DEFAULT VALUES. THERE WAS NO REPORTED PT INVOLVEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HEARTSTART MRX -EMS DEFIBRILLATOR MKJ PHILIPS HEALTHCARE M3536A

    Patients

    Seq Age Sex Outcome Treatment
    1