BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HEART START XL

    MDR report key: 2083135 · Received April 12, 2011

    Report

    Report Number
    1218950-2011-01011
    Event Type
    Malfunction
    Date Received
    April 12, 2011
    Report Date
    March 18, 2011
    Manufacturer
    PHILIPS HEALTHCARE
    Product Code
    MKJ
    PMA / PMN Number
    K001725
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE CUSTOMER REPORTED THAT THE DEVICE FAILED TO POWER UP VIA BATTERY POWER. THE DEVICE WAS EVALUATED BY A PHILIPS FIELD SERVICE ENGINEER. THE SYMPTOM WAS VERIFIED. THE BATTERY WAS RESEATED TO RESOLVE THE ISSUE. WE ARE CONSIDERING THIS A MALFUNCTION RESULTING FROM AN INCOMPLETE CONNECTION BETWEEN THE BATTERY AND THE BATTERY PCA.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT THE DEVICE FAILED TO POWER UP VIA BATTERY POWER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HEART START XL MKJ PHILIPS HEALTHCARE M4735A

    Patients

    Seq Age Sex Outcome Treatment
    1