BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HEARTSTART XL

    MDR report key: 2980485 · Received January 31, 2013

    Report

    Report Number
    1218950-2013-00346
    Event Type
    Malfunction
    Date Received
    January 31, 2013
    Report Date
    January 8, 2013
    Manufacturer
    PHILIPS MEDICAL SYSTEMS
    Product Code
    MKJ
    PMA / PMN Number
    K001725
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    HK
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE CUSTOMER REPORTED THE DEVICE HAD AN (ASP-FAILURE). THIS WAS LATER CLARIFIED BY THE FIELD SERVICE ENGINEER AS A FAILURE TO TURN ON. NO PT INVOLVEMENT WAS REPORTED. A PHILIPS FSE EVALUATED THE DEVICE AND VERIFIED THE FAILURE. THE ISSUE WAS DETERMINED TO BE A FAILURE OF THE ENERGY SELECT SWITCH. THE ENERGY SELECT SWITCH WAS REPLACED TO RESOLVE THE ISSUE. THE DEVICE PASSED ALL TESTING AND REMAINED AT THE CUSTOMER'S SITE.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THE DEVICE HAD AN (ASP-FAILURE). THIS WAS LATER CLARIFIED BY THE FIELD SERVICE ENGINEER AS A FAILURE TO TURN ON. NO PT INVOLVEMENT WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    42017 HEARTSTART XL MKJ PHILIPS MEDICAL SYSTEMS M4735A

    Patients

    Seq Age Sex Outcome Treatment
    1