BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HEART START XL

    MDR report key: 1913729 · Received November 23, 2010

    Report

    Report Number
    1218950-2010-02349
    Event Type
    Malfunction
    Date Received
    November 23, 2010
    Report Date
    October 25, 2010
    Manufacturer
    PHILIPS HEALTHCARE
    Product Code
    MKJ
    PMA / PMN Number
    K001725
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4): THE CUSTOMER REPORTED THAT THE DEVICE FAILED TO DELIVER DEFIBRILLATION THERAPY. A BACKUP DEVICE WAS USED. THERE WAS NO NEGATIVE PATIENT IMPACT. THE CUSTOMER'S BIOMED SUBSEQUENTLY REPORTED TO PHILIPS THAT HE HAD REPLACED THE PATIENT CONNECTOR TO RESOLVE THIS MALFUNCTION. PLEASE NOTE THAT THE CUSTOMER DID NOT PROVIDE THE SERIAL NUMBER OF THE DEVICE.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT THE DEVICE FAILED TO DELIVER DEFIBRILLATION THERAPY. A BACKUP DEVICE WAS USED. THERE WAS NO NEGATIVE PATIENT IMPACT.

    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