BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HEART START XL

    MDR report key: 2961737 · Received January 14, 2013

    Report

    Report Number
    1218950-2013-00084
    Event Type
    Malfunction
    Date Received
    January 14, 2013
    Report Date
    December 15, 2012
    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 THAT THE AC POWER LED DID NOT LIGHT WITH AC POWER PLUGGED IN. THE DEVICE WAS FUNCTIONING WITH A CHARGED BATERY. THE DEVICE WAS EVALUATED BY A PHILIPS FSE AND THE SYMPTOM WAS VERIFIED. THE ISSUE WAS LOCALIZED TO A FAILED AC POWER SUPPLY. THE AC POWER SUPPLY WAS REPLACED TO RESOLVE THE ISSUE. THE DEVICE REMAINS AT THE CUSTOMER SITE.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT THE AC POWER LED DID NOT LIGHT WITH AC POWER PLUGGED IN. THERE WAS NO REPORT OF PATIENT INVOLVEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    21211 HEART START XL MKJ PHILIPS MEDICAL SYSTEMS M4735A

    Patients

    Seq Age Sex Outcome Treatment
    1