BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HEART START XL

    MDR report key: 2941719 · Received January 2, 2013

    Report

    Report Number
    1218950-2013-00010
    Event Type
    Malfunction
    Date Received
    January 2, 2013
    Report Date
    December 5, 2012
    Manufacturer
    PHILIPS MEDICAL SYSTEMS
    Product Code
    MKJ
    PMA / PMN Number
    K001725
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE CUSTOMER ISOLATED THE ISSUE TO THE CONTROL PCA. THE CUSTOMER REPLACED THE CONTROL PCA WHICH RESOLVED THE ISSUE. THE DEVICE WAS PLACED BACK INTO SERVICE. WE WILL CONSIDER THIS A MALFUNCTION OF THE CONTROL PCA WHERE THE BATTERY TEST FAILED AND THE DEVICE SHUT DOWN. AS OF (B)(6) 2012, THE CUSTOMER HAS NOT REPORTED ANY FURTHER TROUBLE WITH THIS DEVICE.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED DURING SYSTEM CHECK, THE BATTERY TEST FAILED THEN THE DEVICE TURNED OFF.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1625 HEART START XL MKJ PHILIPS MEDICAL SYSTEMS M4735A

    Patients

    Seq Age Sex Outcome Treatment
    1 Life Threatening