BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HEARTSTART MRX

    MDR report key: 3060107 · Received March 20, 2013

    Report

    Report Number
    1218950-2013-00972
    Event Type
    Malfunction
    Date Received
    March 20, 2013
    Report Date
    February 22, 2013
    Manufacturer
    PHILIPS MEDICAL SYSTEMS
    Product Code
    MKJ
    PMA / PMN Number
    K031187
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE CUSTOMER REPORTED THAT THE DEVICE INDICATED A RUNTIME THERAPY PCA RELATED ERROR. THERE WAS NO REPORTED PT INVOLVEMENT. 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 THAT THE DEVICE INDICATED A RUNTIME THERAPY PCA RELATED ERROR. THERE WAS NO REPORTED PT INVOLVEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    116612 HEARTSTART MRX MKJ PHILIPS MEDICAL SYSTEMS M3535A

    Patients

    Seq Age Sex Outcome Treatment
    1