BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HEARTSTART MRX

    MDR report key: 3043386 · Received March 11, 2013

    Report

    Report Number
    1218950-2013-00856
    Event Type
    Malfunction
    Date Received
    March 11, 2013
    Report Date
    February 12, 2013
    Manufacturer
    PHILIPS MEDICAL SYSTEMS
    Product Code
    MKJ
    PMA / PMN Number
    K031187
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE DEVICE FAILED TO POWER UP DURING SERVICING AT PHILIPS. THIS WAS DISCOVERED DURING SERVICING, THERE WAS NO PATIENT INVOLVEMENT. THE BENCH TECHNICIAN LOCALIZED THE ISSUE TO A FAILED PROCESSOR PCA. THE PROCESSOR PCA WAS REPLACED TO RESOLVE THE ISSUE. THE DEVICE PASSED ALL TESTING AND WAS SHIPPED BACK TO THE CUSTOMER. THIS WAS A MALFUNCTION OF THE PROCESSOR PCA.

    Description of Event or Problem · 1

    THE DEVICE FAILED TO POWER UP DURING SERVICING AT PHILIPS. THIS WAS DISCOVERED DURING SERVICING, THERE WAS NO PATIENT INVOLVEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    102728 HEARTSTART MRX MKJ PHILIPS MEDICAL SYSTEMS M3535A

    Patients

    Seq Age Sex Outcome Treatment
    1