BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HEARTSTART MRX

    MDR report key: 2043238 · Received March 15, 2011

    Report

    Report Number
    1218950-2011-00702
    Event Type
    Malfunction
    Date Received
    March 15, 2011
    Report Date
    February 14, 2011
    Manufacturer
    PHILIPS HEALTHCARE
    Product Code
    MKJ
    PMA / PMN Number
    K031187
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4): THE CUSTOMER REPORTED THAT THE DEVICE WOULD NOT RECOGNIZE MULTIPLE, KNOWN TO BE GOOD, THERAPY CABLES. THERE WAS NO REPORT OF PT INVOLVEMENT OR ADVERSE PT IMPACT. 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 THE DEVICE WOULD NOT RECOGNIZE MULTIPLE, KNOWN TO BE GOOD, THERAPY CABLES. THERE WAS NO REPORT OF PT INVOLVEMENT OR ADVERSE PT IMPACT.

    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