BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HEART START XL

    MDR report key: 2823658 · Received October 9, 2012

    Report

    Report Number
    1218950-2012-03362
    Event Type
    Malfunction
    Date Received
    October 9, 2012
    Report Date
    September 13, 2012
    Manufacturer
    PHILIPS MEDICAL SYSTEMS
    Product Code
    MKJ
    PMA / PMN Number
    K001725
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE DEVICE WAS EVALUATED AT PHILIPS AND THE FAILURE WAS VERIFIED. THE CONTROL PCA AND THE POWER PCA WERE REPLACED TO RESOLVE THE ISSUE. THE DEVICE WAS RETURNED TO THE CUSTOMER SITE. WE CANNOT DETERMINE THE CAUSE OF THE FAILURE AS MULTIPLE PARTS WERE REPLACED.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THE DEFIBRILLATOR IS NOT GETTING A CHARGE LED. NO PATIENT INVOLVEMENT WAS REPORTED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1