BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HEART START XL

    MDR report key: 3043440 · Received March 12, 2013

    Report

    Report Number
    1218950-2013-00817
    Event Type
    Malfunction
    Date Received
    March 12, 2013
    Report Date
    February 14, 2013
    Manufacturer
    PHILIPS MEDICAL SYSTEMS
    Product Code
    MKJ
    PMA / PMN Number
    K001725
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SF
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4): THE CUSTOMER REPORTED NEEDED TO REPAIR THE BATTERY RELEASE BUTTON. PHILIPS IS REPORTING THIS INCIDENT AS A BROKEN BATTERY RELEASE BUTTON COULD IMPACT THE DELIVERY OF THERAPY AS IT COULD PREVENT THE UNIT FROM POWERING UP ON BATTERY POWER. THE COMPLAINT IS STILL UNDER INVESTIGATION. A F/U REPORT WILL BE SUBMITTED ONCE THE INVESTIGATION IS COMPLETE.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED NEEDED TO REPAIR THE BATTERY RELEASE BUTTON. PHILIPS IS REPORTING THIS INCIDENT AS A BROKEN BATTERY RELEASE BUTTON COULD IMPACT THE DELIVERY OF THERAPY AS IT COULD PREVENT THE UNIT FROM POWERING UP ON BATTERY POWER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    104503 HEART START XL MKJ PHILIPS MEDICAL SYSTEMS M4735A

    Patients

    Seq Age Sex Outcome Treatment
    1