BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HEART START XL

    MDR report key: 3043463 · Received March 13, 2013

    Report

    Report Number
    1218950-2013-00869
    Event Type
    Malfunction
    Date Received
    March 13, 2013
    Report Date
    February 22, 2013
    Manufacturer
    PHILIPS MEDICAL SYSTEMS
    Product Code
    MKJ
    PMA / PMN Number
    K001725
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE CUSTOMER REPORTED THE CHARGE LED INDICATOR IS NOT GLOWING. THERE WAS NO REPORT OF PT INVOLVEMENT. THE MODE DURING USE WAS NOT REPORTED. THIS COMPLAINT IS STILL BEING INVESTIGATED. A F/U REPORT WILL BE SUBMITTED UPON COMPLETION OF THE INVESTIGATION.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THE CHARGE LED INDICATOR IS NOT GLOWING. THERE WAS NO REPORT OF PT INVOLVEMENT. THE MODE DURING USE WAS NOT REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    106240 HEART START XL MKJ PHILIPS MEDICAL SYSTEMS M4735A

    Patients

    Seq Age Sex Outcome Treatment
    1