BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HEARTSTART XL

    MDR report key: 3063432 · Received March 28, 2013

    Report

    Report Number
    1218950-2013-01138
    Event Type
    Malfunction
    Date Received
    March 28, 2013
    Report Date
    June 8, 2012
    Manufacturer
    PHILIPS MEDICAL SYSTEMS
    Product Code
    MKJ
    PMA / PMN Number
    K001725
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE CUSTOMER REPORTED THAT THE DEVICE FAILED TO POWER UP. NO PATIENT INVOLVEMENT WAS REPORTED. THE CUSTOMER HAD STATED THAT THEY THOUGHT WATER DAMAGE HAD IMPACTED THE DEVICE POWER. PHILIPS (B)(4) EVALUATED THE DEVICE AND VERIFIED THE REPORTED SYMPTOM. NO WATER DAMAGE WAS EVIDENT. PHILIPS FOUND THAT AN INTERNAL CABLE WAS LOOSE WHICH PREVENTED THE DEVICE FROM POWERING ON. THE CABLE WAS CONNECTED PROPERLY AND THE DEVICE PASSED ALL TESTING BEFORE BEING RETURNED TO SERVICE. THE FAILURE TO POWER UP WAS DUE TO A LOOSE CABLE CONNECTION.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT THE DEVICE FAILED TO POWER UP. NO PATIENT INVOLVEMENT WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    129200 HEARTSTART XL MKJ PHILIPS MEDICAL SYSTEMS M4735A

    Patients

    Seq Age Sex Outcome Treatment
    1