BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HEARTSTART XL

    MDR report key: 4210388 · Received August 8, 2014

    Report

    Report Number
    1218950-2014-04569
    Event Type
    Malfunction
    Date Received
    August 8, 2014
    Report Date
    December 22, 2011
    Manufacturer
    PHILIPS MEDICAL SYSTEMS
    Product Code
    MKJ
    PMA / PMN Number
    K001725
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    HK
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    THE CUSTOMER CALLED INTO PHILIPS HEALTHCARE TO REPORT AN UNSPECIFIED "SYSTEM ERROR" ON THE DEVICE. NO OTHER DESCRIPTION AVAILABLE. THERE WAS NO REPORTED PATIENT INVOLVEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    468831 HEARTSTART XL MKJ PHILIPS MEDICAL SYSTEMS M4735A

    Patients

    Seq Age Sex Outcome Treatment
    1