BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HEARTSTART MRX

    MDR report key: 3043389 · Received March 11, 2013

    Report

    Report Number
    1218950-2013-00859
    Event Type
    Malfunction
    Date Received
    March 11, 2013
    Report Date
    February 13, 2013
    Manufacturer
    PHILIPS MEDICAL SYSTEMS
    Product Code
    MKJ
    PMA / PMN Number
    K031187
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    HI, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE DEVICE WAS SENT TO THE PHILIPS BENCH FOR EVALUATION. THE REPORTED SYMPTOM WAS CONFIRMED AS CHARGE/SHOCK ERRORS WERE NOTED IN THE STATUS LOG. THE THERAPY PCA WAS REPLACED TO RESOLVE THE ISSUE. THE DEVICE PASSED ALL TESTING AND WAS RETURNED TO THE CUSTOMER SITE FOR USE. A MALFUNCTION OF THE THERAPY PCA CAUSED THE CHARGE/SHOCK ERROR. REPLACEMENT OF THE THERAPY PCA RESOLVED THE ISSUE.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED A CHARGE/SHOCK FAILURE ERROR MESSAGE. THERE WAS NO NEGATIVE PATIENT IMPACT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    102729 HEARTSTART MRX MKJ PHILIPS MEDICAL SYSTEMS M3535A

    Patients

    Seq Age Sex Outcome Treatment
    1