BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HEARTSTART MRX

    MDR report key: 1960787 · Received December 17, 2010

    Report

    Report Number
    1218950-2010-02624
    Event Type
    Malfunction
    Date Received
    December 17, 2010
    Report Date
    November 19, 2010
    Manufacturer
    PHILIPS HEALTHCARE
    Product Code
    MKJ
    PMA / PMN Number
    K031187
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4): THE CUSTOMER REPORTED THAT THEY BELIEVED A SHOCK WAS NOT DELIVERED, ALTHOUGH THE EVENT FILES INDICATED THE SHOCKS HAD BEEN DELIVERED. THERE WAS NO NEGATIVE IMPACT TO THE INVOLVED PT. THIS COMPLAINT IS STILL BEING INVESTIGATED. A FOLLOW-UP REPORT WILL BE SUBMITTED UPON COMPLETION OF THE INVESTIGATION.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT THEY BELIEVED A SHOCK WAS NOT DELIVERED, ALTHOUGH THE EVENT FILES INDICATED THE SHOCKS HAD BEEN DELIVERED. THERE WAS NO NEGATIVE IMPACT TO THE INVOLVED PT.

    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