BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HEART START XL

    MDR report key: 2974525 · Received January 28, 2013

    Report

    Report Number
    1218950-2013-00290
    Event Type
    Malfunction
    Date Received
    January 28, 2013
    Report Date
    January 7, 2013
    Manufacturer
    PHILIPS MEDICAL SYSTEMS
    Product Code
    MKJ
    PMA / PMN Number
    K001725
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE DEVICE WAS EVALUATED BY A PHILIPS FIELD SERVICE ENGINEER AND THE ISSUE WAS VERIFIED. THE CONTROL PCA WAS FOUND TO BE DEFECTIVE. REPLACING THE CONTROL PCA RESOLVED THE REPORTED ISSUE. THE DEVICE PASSED TESTING AND WAS RETURNED TO THE CUSTOMER.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THE DEVICE DID NOT DISPLAY. THERE WAS NO REPORT OF PT INVOLVEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    38512 HEART START XL MKJ PHILIPS MEDICAL SYSTEMS M4735A

    Patients

    Seq Age Sex Outcome Treatment
    1