BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HEART START XL

    MDR report key: 2960993 · Received January 15, 2013

    Report

    Report Number
    1218950-2013-00085
    Event Type
    Malfunction
    Date Received
    January 15, 2013
    Report Date
    December 17, 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 DEVICE WAS EVALUATED BY A PHILIPS FIELD SVC ENGINEER AND 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 PASSED ALL TESTING AND REMAINED 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. THE DEVICE WAS FUNCTIONING WITH A CHARGED BATTERY. NO ADVERSE PT IMPACT WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    23085 HEART START XL MKJ PHILIPS MEDICAL SYSTEMS M4735A

    Patients

    Seq Age Sex Outcome Treatment
    1