BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HEART START XL

    MDR report key: 1843832 · Received September 10, 2010

    Report

    Report Number
    1218950-2010-01571
    Event Type
    Malfunction
    Date Received
    September 10, 2010
    Report Date
    August 13, 2010
    Manufacturer
    PHILIPS HEALTHCARE
    Product Code
    MKJ
    PMA / PMN Number
    K001725
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4): THE CUSTOMER REPORTED THAT THE DEVICE DISPLAYED ERROR F0007 AND 20003. ON (B)(6)2010, PHILIPS WORKED WITH THE CUSTOMER TO DETERMINE THAT THE CONTROL PCA WAS FAULTY. A REPLACEMENT CONTROL PCA WAS ORDERED TO RESOLVE THE REPORTED ISSUE. AS OF 9/10/10, THE CUSTOMER HAS NOT CALLED BACK REQUESTING FURTHER SUPPORT.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT THE DEVICE DISPLAYED ERROR F0007 AND 20003.

    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