BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HEART START XL

    MDR report key: 4232458 · Received September 17, 2014

    Report

    Report Number
    1218950-2014-05596
    Event Type
    Malfunction
    Date Received
    September 17, 2014
    Report Date
    August 22, 2014
    Manufacturer
    PHILIPS MEDICAL SYSTEMS
    Product Code
    MKJ
    PMA / PMN Number
    K001725
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BR
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    IT WAS INITIALLY REPORTED TO PHILIPS HEALTHCARE THAT THE HEARTSTART XL DISPLAYED AN ERROR MESSAGE. IT WAS LATER CLARIFIED BY THE PHILIP FIELD SERVICE ENGINEER (FSE) THAT THE DEVICE COULD NOT MEASURE ECG. THERE WAS NO PT INVOLVEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    574484 HEART START XL MKJ PHILIPS MEDICAL SYSTEMS M4735A

    Patients

    Seq Age Sex Outcome Treatment
    1