BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HEART START XL

    MDR report key: 2043217 · Received March 15, 2011

    Report

    Report Number
    1218950-2011-00699
    Event Type
    Malfunction
    Date Received
    March 15, 2011
    Report Date
    February 18, 2011
    Manufacturer
    AGILENT TECHNOLOGIES, INC.
    Product Code
    MKJ
    PMA / PMN Number
    K001725
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4): THE CUSTOMER REPORTED THE UNIT WOULD NOT POWER UP BY BATTERY POWER. A PHILIPS REPRESENTATIVE EVALUATED THE UNIT. THE REPORTED SYMPTOM WAS DUPLICATED. REPLACING THE POWER SUPPLY RESOLVED THE ISSUE. WE WILL CONSIDER THIS A POWER SUPPLY MALFUNCTION.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THE UNIT WOULD NOT POWER UP BY BATTERY POWER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HEART START XL MKJ AGILENT TECHNOLOGIES, INC. M4735A

    Patients

    Seq Age Sex Outcome Treatment
    1