BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HEART START XL

    MDR report key: 2223232 · Received August 16, 2011

    Report

    Report Number
    1218950-2011-02406
    Event Type
    Malfunction
    Date Received
    August 16, 2011
    Report Date
    July 20, 2011
    Manufacturer
    PHILIPS HEALTHCARE - ANDOVER
    Product Code
    MKJ
    PMA / PMN Number
    K001725
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE CUSTOMER REPORTED THE DEVICE FAILED THE SHIFT TEST. THE DEVICE DID NOT DETECT THE PADS/PADDLES CABLE AND DID NOT PRESENT THE RELATED PROMPTS. THERE WAS NO PATIENT INVOLVEMENT. THE PHILIPS CUSTOMER REPAIR CENTER (CRC) EVALUATED THE DEVICE AND CONFIRMED THIS MALFUNCTION, WHICH WAS RESOLVED BY REPLACEMENT OF THE POWER PCA.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THE DEVICE FAILED THE SHIFT TEST. THE DEVICE DID NOT DETECT THE PADS/PADDLES CABLE AND DID NOT PRESENT THE RELATED PROMPTS. THERE WAS NO PATIENT INVOLVEMENT.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1