BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HEARTSTART XL

    MDR report key: 3063438 · Received March 28, 2013

    Report

    Report Number
    1218950-2013-01109
    Event Type
    Malfunction
    Date Received
    March 28, 2013
    Report Date
    June 22, 2012
    Manufacturer
    PHILIPS MEDICAL SYSTEMS
    Product Code
    MKJ
    PMA / PMN Number
    K001725
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BR
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4): THE CUSTOMER REPORTED A DEFECT IN THE ROTATING KEY. IT WAS LATER CLARIFIED THE DEVICE FAILED TO POWER UP. THE DEVICE WAS EVALUATED BY A PHILIPS REP. THE REPORTED SYMPTOM WAS CONFIRMED. THE ISSUE WAS ISOLATED TO THE ENERGY SELECT SWITCH. THE ENERGY SELECT SWITCH WAS REPLACED TO RESOLVE THE ISSUE. THE DEVICE PASSED ALL REQUIRED TESTING AND REMAINS AT THE CUSTOMER SITE FOR USE. THE INVESTIGATED FAILURES OF THE ENERGY SELECT SWITCHES RESULTED IN (B)(4) FOR THE MRX. THE FAILURE MODES INCLUDE A SPONTANEOUS TURN-ON AND A FAILURE TO POWER UP. THE DEVICES AFFECTED BY THIS FCO ARE LISTED BY SERIAL NUMBER. THIS DEVICE IS WITHIN THE FCO SERIAL NUMBER RANGE. THIS WAS MALFUNCTION OF THE ENERGY SELECT SWITCH. REPLACEMENT OF THE ENERGY SELECT SWITCH RESOLVED THE ISSUE.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED A DEFECT IN THE ROTATING KEY. IT WAS LATER CLARIFIED THE DEVICE FAILED TO POWER UP.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    129204 HEARTSTART XL MKJ PHILIPS MEDICAL SYSTEMS M4735A

    Patients

    Seq Age Sex Outcome Treatment
    1