BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HEART START XL

    MDR report key: 2000142 · Received February 18, 2011

    Report

    Report Number
    1218950-2011-00453
    Event Type
    Malfunction
    Date Received
    February 18, 2011
    Report Date
    January 24, 2011
    Manufacturer
    PHILIPS HEALTHCARE
    Product Code
    MKJ
    PMA / PMN Number
    K001725
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SP
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4): THE CUSTOMER REPORTED THAT THE AC POWER AND THE BATT CHARGE LEDS WERE NOT LIT. WHEN THE UNIT WAS POWERED UP, THERE WAS A "LOW BATTERY" SCREEN ALERT. THERE WAS NO REPORT OF PT INVOLVEMENT. A PHILIPS FIELD SERVICE ENGINEER EVALUATED THAT UNIT AND VERIFIED THE FAILURE. REPLACEMENT OF THE POWER SUPPLY RESOLVED THE FAILURE.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT THE AC POWER AND THE BATT CHARGE LEDS WERE NOT LIT. WHEN THE UNIT WAS POWERED UP, THERE WAS A "LOW BATTERY" SCREEN ALERT. THERE WAS NO REPORT OF PT INVOLVEMENT.

    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