BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HEARTSTART MRX -EMS DEFIBRILLATOR

    MDR report key: 2083147 · Received April 13, 2011

    Report

    Report Number
    1218950-2011-01021
    Event Type
    Malfunction
    Date Received
    April 13, 2011
    Report Date
    March 18, 2011
    Manufacturer
    PHILIPS HEALTHCARE
    Product Code
    MKJ
    PMA / PMN Number
    K031187
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE CUSTOMER REPORTED THAT THE UNIT FAILED TO POWER UP. PHILIPS HAS RECEIVED NO INFO SUPPORTING THAT THIS UNIT WAS BEING USED FOR EITHER DIAGNOSIS OR TREATMENT OF A PT WHEN THE PROBLEM WAS OBSERVED. NO ADVERSE IMPACT WAS REPORTED. PHILIPS EVALUATED THE DEVICE AND WAS ABLE TO CONFIRM THE CUSTOMER'S REPORTED PROBLEM. THE DEVICE WAS REPAIRED BY REPLACING THE PROCESSOR PCA. THE DEVICE PASSED ALL TESTING AND WAS RETURNED TO THE CUSTOMER.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT THE UNIT FAILED TO POWER UP. PHILIPS HAS RECEIVED NO INFO SUPPORTING THAT THIS UNIT WAS BEING USED FOR EITHER DIAGNOSIS OR TREATMENT OF A PT WHEN THE PROBLEM WAS OBSERVED. NO ADVERSE IMPACT WAS REPORTED.

    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