BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HEARTSTART MRX

    MDR report key: 2091268 · Received April 20, 2011

    Report

    Report Number
    1218950-2011-01094
    Event Type
    Malfunction
    Date Received
    April 20, 2011
    Report Date
    March 23, 2011
    Manufacturer
    PHILIPS HEALTHCARE
    Product Code
    MKJ
    PMA / PMN Number
    K031187
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE CUSTOMER REPORTED THAT THE DEVICE FAILED OP CHECK AND THAT IT WAS NOT DETECTING MULTIPLE BATTERIES IN COMPARTMENT B. THE DEVICE WAS EVALUATED AT PHILIPS. THE SYMPTOM COULD NOT BE DUPLICATED. THE DEVICE WAS TESTED WITH TWO DIFFERENT BATTERIES IN COMPARTMENT B AND THEY WERE BOTH RECOGNIZED. THE DEVICE PASSED ALL TESTING AND WAS PLACED BACK INTO SERVICE.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT THE DEVICE FAILED OP CHECK AND THAT IT WAS NOT DETECTING MULTIPLE BATTERIES IN COMPARTMENT B.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HEARTSTART MRX MKJ PHILIPS HEALTHCARE M3535A

    Patients

    Seq Age Sex Outcome Treatment
    1