BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HEART START XL

    MDR report key: 2511354 · Received March 15, 2012

    Report

    Report Number
    1218950-2012-00931
    Event Type
    Malfunction
    Date Received
    March 15, 2012
    Report Date
    February 21, 2012
    Manufacturer
    PHILIPS MEDICAL SYSTEMS / DUP
    Product Code
    MKJ
    PMA / PMN Number
    K001725
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TW
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE CUSTOMER REPORTED THAT THE PACER TEST FAILED. THE DEVICE WAS EVALUATED BY PHILIPS. THE POWER PCA WAS REPLACED TO RESOLVE THE ISSUE.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT THE PACER TEST FAILED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1