BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HEARTSTART MRX

    MDR report key: 1924953 · Received December 10, 2010

    Report

    Report Number
    1218950-2010-02529
    Event Type
    Malfunction
    Date Received
    December 10, 2010
    Report Date
    July 26, 2010
    Manufacturer
    PHILIPS HEALTHCARE
    Product Code
    MKJ
    PMA / PMN Number
    K031187
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PL
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4) 2010, THE LOCAL PHILIPS SUBSIDIARY REPORTED THAT THE DEVICE HAD BEEN SERVICED. THE DEVICE FAILED THE OPCHECK TEST. PER THE SERVICE MANUAL, THE POWER PCA WAS REPLACED. THE DEVICE PASSED ALL TESTING AND WAS RETURNED TO SERVICE. THERE WAS NO REPORTED PT INVOLVEMENT. ON (B)(4) 2010, THE LOCAL PHILIPS REP PROVIDED NEW INFO THAT MAKES THIS COMPLAINT REPORTABLE. THE LOCAL PHILIPS REP VISITED THE CUSTOMER SITE AND COLLECTED THE DEVICE ERROR LOG. THE ERROR LOG WAS FOUND TO CONTAIN SUPPLY VOLTAGE ERRORS AND CHARGE/SHOCK ERRORS. WE WILL CONSIDER THIS TO BE A MALFUNCTION OF THE POWER PCA.

    Description of Event or Problem · 1

    ON (B)(6) 2010, THE LOCAL PHILIPS SUBSIDIARY REPORTED THAT THE DEVICE HAD BEEN SERVICED. THE DEVICE FAILED THE OPCHECK TEST. PER THE SERVICE MANUAL, THE POWER PCA WAS REPLACED. THE DEVICE PASSED ALL TESTING AND WAS RETURNED TO SERVICE. THERE WAS NO REPORTED PT INVOLVEMENT. ON (B)(6) 2010, THE LOCAL PHILIPS REP PROVIDED NEW INFO THAT MAKES THIS COMPLAINT REPORTABLE. THE LOCAL PHILIPS REP VISITED THE CUSTOMER SITE AND COLLECTED THE DEVICE ERROR LOG. THE ERROR LOG WAS FOUND TO CONTAIN SUPPLY VOLTAGE ERRORS AND CHARGE/SHOCK ERRORS.

    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