BEUDAMED
    FDA Adverse Event Other Summary report: N

    HEARTSTART MRX

    MDR report key: 1637734 · Received March 18, 2010

    Report

    Report Number
    1218950-2010-00339
    Event Type
    Other
    Date Received
    March 18, 2010
    Report Date
    February 17, 2010
    Manufacturer
    PHILIPS MEDICAL SYSTEMS
    Product Code
    MKJ
    PMA / PMN Number
    K031187
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    A PHILIPS FIELD SERVICE ENGINEER EVALUATED THE DEVICE AND THERE WAS NO MALFUNCTION. THE DEVICE PASSED ALL STANDARD TESTING AND WAS RETURNED TO SERVICE. THE MRX INSTRUCTIONS FOR USE STATES THAT "THE PRESENCE OR ABSENCE OF A MUSCULAR RESPONSE TO THE TRANSFER OF ENERGY DURING ELECTRICAL THERAPY IS NOT A RELIABLE INDICATOR OF ENERGY DELIVERY OR DEVICE PERFORMANCE." THE DEVICE WAS FUNCTIONING AS DESIGNED AND INTENDED, AND THERE WAS NO MALFUNCTION. THIS INFORMATION WAS PROVIDED TO THE CUSTOMER.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT A NEONATE HAD AN UNEXPECTED MUSCULAR RESPONSE WHEN A "NO SHOCK DELIVERED" MESSAGE WAS HEARD. THE CUSTOMER STATED THAT THERE WAS NO NEGATIVE PT IMPACT.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1