BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HEART START XL

    MDR report key: 3063448 · Received March 28, 2013

    Report

    Report Number
    1218950-2013-01146
    Event Type
    Malfunction
    Date Received
    March 28, 2013
    Report Date
    January 9, 2013
    Manufacturer
    PHILIPS MEDICAL SYSTEMS
    Product Code
    MKJ
    PMA / PMN Number
    K001725
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE CUSTOMER INITIALLY REPORTED A SPARE PARTS ORDER THAT WAS LATER CLARIFIED TO BE A FAILURE TO POWER ON. THERE WAS NO REPORT OF PT INVOLVEMENT. THE DEVICE WAS EVALUATED LOCALLY BY PHILIPS AND THE REPORT SYSTEM WAS CONFIRMED. THE CONTROL PCA WAS REPLACED TO RESOLVE THE REPORTED SYMPTOM. AFTER PASSING ALL TESTING THE DEVICE WAS RETURNED TO USE. THE FAILURE TO POWER ON WAS DUE TO A CONTROL PCA MALFUNCTION.

    Description of Event or Problem · 1

    THE CUSTOMER INITIALLY REPORTED A SPARE PARTS ORDER THAT WAS LATER CLARIFIED TO BE A FAILURE TO POWER ON. THERE WAS NO REPORT OF PT INVOLVEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    127316 HEART START XL MKJ PHILIPS MEDICAL SYSTEMS M4735A

    Patients

    Seq Age Sex Outcome Treatment
    1