BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HEARTSTART MRX

    MDR report key: 3060705 · Received March 26, 2013

    Report

    Report Number
    1218950-2013-01046
    Event Type
    Malfunction
    Date Received
    March 26, 2013
    Report Date
    March 6, 2013
    Manufacturer
    PHILIPS MEDICAL SYSTEMS
    Product Code
    MKJ
    PMA / PMN Number
    K031187
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SP
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4): THE CUSTOMER REPORTED A FAILED DX PADS FAILURE. THERE WAS NO PT INVOLVEMENT. THE DEVICE WAS EVALUATED BY A PHILIPS REP. THE REPORTED SYMPTOM WAS CONFIRMED. THE ISSUE WAS ISOLATED TO THE THERAPY PCA. THE THERAPY PCA WAS REPLACED TO RESOLVE THE ISSUE. THE DEVICE THE PASSED ALL REQUIRED TESTING AND REMAINS AT THE CUSTOMER SITE FOR USE. THIS WAS A MALFUNCTION OF THE THERAPY PCA. REPLACEMENT OF THE THERAPY PCA RESOLVED THE ISSUE.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED A FAILED DX PADS FAILURE. THERE WAS NO PT INVOLVEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    123066 HEARTSTART MRX MKJ PHILIPS MEDICAL SYSTEMS M3535A

    Patients

    Seq Age Sex Outcome Treatment
    1