BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HEART START XL

    MDR report key: 3043184 · Received March 13, 2013

    Report

    Report Number
    1218950-2013-00896
    Event Type
    Malfunction
    Date Received
    March 13, 2013
    Report Date
    February 18, 2013
    Manufacturer
    PHILIPS MEDICAL SYSTEMS
    Product Code
    MKJ
    PMA / PMN Number
    K001725
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TW
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE CUSTOMER REPORTED THAT THE DEVICE CAN'T BOOT UP (FAILS TO POWER UP). NO PT INVOLVEMENT WAS REPORTED. THE DEVICE WAS EVALUATED BY A PHILIPS FSE AND THE SYMPTOM WAS VERIFIED. THE POWER PCA WAS IDENTIFIED AS THE CAUSE. THE POWER PCA WAS REPLACED TO RESOLVE THE ISSUE. THE DEVICE PASSED ALL REQUIRED TESTING AND REMAINS AT THE CUSTOMER SITE. WE ARE CONSIDERING THIS A MALFUNCTION OF THE POWER PCA.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT THE DEVICE CAN'T BOOT UP (FAILS TO POWER UP). NO PT INVOLVEMENT WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    106248 HEART START XL MKJ PHILIPS MEDICAL SYSTEMS M4735A

    Patients

    Seq Age Sex Outcome Treatment
    1