BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HEARTSTART MRX

    MDR report key: 2000154 · Received February 18, 2011

    Report

    Report Number
    1218950-2011-00454
    Event Type
    Malfunction
    Date Received
    February 18, 2011
    Report Date
    January 24, 2011
    Manufacturer
    PHILIPS HEALTHCARE
    Product Code
    MKJ
    PMA / PMN Number
    K031187
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE CUSTOMER REPORTED TO THE PHILIPS CUSTOMER CARE CENTER THAT THE AC POWER MODULE WAS NOT WORKING. IT WAS EVALUATED LOCALLY BY THE CUSTOMER. GIVEN THE INFO PROVIDED BY THE CUSTOMER, THE PHILIPS CUSTOMER CARE CENTER DETERMINED THAT THE AC POWER MODULE HAD FAILED. THE CUSTOMER WAS PROVIDED WITH ORDERING INFO. NO FURTHER CALLS HAVE BEEN MADE BY THE CUSTOMER REGARDING THIS ISSUE.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED TO THE PHILIPS CUSTOMER CARE CENTER THAT THE AC POWER MODULE WAS NOT WORKING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HEARTSTART MRX MKJ PHILIPS HEALTHCARE M3535A

    Patients

    Seq Age Sex Outcome Treatment
    1