BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HEART START XL

    MDR report key: 2082033 · Received April 26, 2011

    Report

    Report Number
    1218950-2011-01146
    Event Type
    Malfunction
    Date Received
    April 26, 2011
    Report Date
    March 29, 2011
    Manufacturer
    PHILIPS HEALTHCARE
    Product Code
    MKJ
    PMA / PMN Number
    K001725
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4): THE CUSTOMER REPORTED MULTIPLE PROBLEMS WITH OP CHECK INCLUDING PROBLEMS WITH CHARGING AND DISCHARGING. PHILIPS DISCUSSED THE POSSIBILITY OF USER ERRORS DURING OP CHECK WITH THE CALLER, AS THE CALLER INDICATED THAT SHE COULD NOT REPRODUCE THE OP CHECK ISSUES. THE CALLER INDICATED THAT SHE FELT THAT THE OP CHECK ISSUES WERE CAUSED BY USER ERROR BUT SHE WAS NOT SURE. THE CUSTOMER CHOSE TO SEND THE DEVICE IN FOR EVALUATION. THE DEVICE WAS EVALUATED AT PHILIPS. THE SYMPTOM COULD NOT BE REPRODUCED. NO CRITICAL ERRORS WERE NOTED IN THE ERROR LOG. THE DEVICE PASSED ALL FUNCTIONAL AND SAFETY TESTS. WE ARE CONSIDERING THIS A MALFUNCTION BUT CANNOT DETERMINE THE CAUSE AS THE SYMPTOM COULD NOT BE REPRODUCED.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED MULTIPLE PROBLEMS WITH OP CHECK INCLUDING PROBLEMS WITH CHARGING AND DISCHARGING.

    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