BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HEARTSTART MRX -EMS DEFIBRILLATOR

    MDR report key: 2241481 · Received August 9, 2011

    Report

    Report Number
    1218950-2011-02322
    Event Type
    Malfunction
    Date Received
    August 9, 2011
    Report Date
    July 13, 2011
    Manufacturer
    PHILIPS HEALTHCARE - ANDOVER
    Product Code
    MKJ
    PMA / PMN Number
    K031187
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NV, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE CUSTOMER REPORTED THAT THE UNIT RESETS WHEN THE CHARGE BUTTON IS PRESSED WHEN RUNNING THE OPERATIONAL CHECK. THERE WAS NO REPORT OF PT INVOLVEMENT. THE FIELD SERVICE ENGINEER EVALUATED THE UNIT. THE REPORTED FAILURE COULD NOT BE REACHED AND THE DEVICE PASSED ALL TESTING. WE CANNOT DETERMINE THE CAUSE OF THIS REPORTED ISSUE.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT THE UNIT RESETS WHEN THE CHARGE BUTTON IS PRESSED WHEN RUNNING THE OPERATIONAL CHECK. THERE WAS NO REPORT OF PT INVOLVEMENT.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1