BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HEARTSTART MRX - EMS DEFIBRILLATOR

    MDR report key: 2091267 · Received April 20, 2011

    Report

    Report Number
    1218950-2011-01107
    Event Type
    Malfunction
    Date Received
    April 20, 2011
    Report Date
    March 28, 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 THAT WHEN ATTEMPTING TO FAX A 12 LEAD ECG OVER BLUETOOTH CONNECTION, THE DEVICE UNEXPECTEDLY SHUT DOWN. THERE WAS NO ADVERSE PATIENT IMPACT AS STATED BY THE CUSTOMER. ON (B)(6) 2011, A PHILIPS FIELD SERVICE ENGINEER EVALUATED THE DEVICE AND NO TROUBLE WAS FOUND. THE DEVICE PASSED ALL PERFORMANCE VERIFICATION TESTS AND WAS RETURNED TO USE.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT WHEN ATTEMPTING TO FAX A 12 LEAD ECG OVER BLUETOOTH CONNECTION, THE DEVICE UNEXPECTEDLY SHUT DOWN. THERE WAS NO ADVERSE PATIENT IMPACT AS STATED BY THE CUSTOMER.

    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