BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HEARTSTART MRX

    MDR report key: 3003565 · Received February 11, 2013

    Report

    Report Number
    1218950-2013-00491
    Event Type
    Malfunction
    Date Received
    February 11, 2013
    Report Date
    January 17, 2013
    Manufacturer
    PHILIPS MEDICAL SYSTEMS
    Product Code
    MKJ
    PMA / PMN Number
    K031187
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE CUSTOMER REPORTED HAVING INTERMITTENT POWER ISSUES. THE DEVICE, BATTERY AND AC POWER MODULE WERE EVALUATED AT THE PHILIPS BENCH. THE SYMPTOM COULD NOT BE DUPLICATED. THE POWER PCA WAS REPLACED AT THE DISCRETION OF THE TECH TO ADDRESS THE REPORTED SYMPTOM. THE DEVICE REMAINS AT THE CUSTOMER SITE. BASED ON THE CUSTOMER¿S REPORT WE ARE CONSIDERING THIS A MALFUNCTION. WE CANNOT DETERMINE THE CAUSE SINCE THE SYMPTOM COULD NOT BE DUPLICATED.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED HAVING INTERMITTENT POWER ISSUES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    60161 HEARTSTART MRX MKJ PHILIPS MEDICAL SYSTEMS M3535A

    Patients

    Seq Age Sex Outcome Treatment
    1