BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HEART START XL

    MDR report key: 2140606 · Received June 16, 2011

    Report

    Report Number
    1218950-2011-01718
    Event Type
    Malfunction
    Date Received
    June 16, 2011
    Report Date
    May 19, 2011
    Manufacturer
    PHILIPS HEALTHCARE
    Product Code
    MKJ
    PMA / PMN Number
    K001725
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE CUSTOMER REPORTED THAT THE UNIT SHOWED AN ERROR 1000. THERE WAS NO REPORT OF PATIENT INVOLVEMENT. THE UNIT WAS EVALUATED AT PHILIPS AND THE FAILURE WAS VERIFIED. REPLACEMENT OF THE POWER PCA RESOLVE THE FAILURE. THE UNIT PASSED ALL POST SERVICING TESTING AND WAS SHIPPED BACK TO THE CUSTOMER SITE.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT THE UNIT SHOWED AN ERROR 1000. THERE WAS NO REPORT OF PATIENT 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