BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HEART START XL

    MDR report key: 1913726 · Received November 23, 2010

    Report

    Report Number
    1218950-2010-02353
    Event Type
    Malfunction
    Date Received
    November 23, 2010
    Report Date
    September 5, 2010
    Manufacturer
    PHILIPS HEALTHCARE
    Product Code
    MKJ
    PMA / PMN Number
    K001725
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4): THE CUSTOMER REPORTED A PROBLEM WITH THE DEVICE AND REQUESTED SERVICING. THERE WAS NO REPORTED PATIENT INVOLVEMENT. ON (B)(4), 2010, NEW INFORMATION WAS PROVIDED BY A LOCAL 3RD PARTY REPAIR SERVICE TO WHOM THE DEVICE HAD BEEN SENT FOR EVALUATION AND REPAIR. IT WAS CLARIFIED THAT THE SYMPTOM WAS A BLANK DISPLAY. THE PROBLEM WAS RESOLVED BY REPLACEMENT OF THE INVERTER BOARD.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED A PROBLEM WITH THE DEVICE AND REQUESTED SERVICING. THERE WAS NO REPORTED PATIENT INVOLVEMENT. ON (B)(6), 2010, NEW INFORMATION WAS PROVIDED BY A LOCAL 3RD PARTY REPAIR SERVICE TO WHOM THE DEVICE HAD BEEN SENT FOR EVALUATION AND REPAIR. IT WAS CLARIFIED THAT THE SYMPTOM WAS A BLANK DISPLAY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HEART START XL MKJ PHILIPS HEALTHCARE M4735A

    Patients

    Seq Age Sex Outcome Treatment
    1