BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HEARTSTART MRX

    MDR report key: 2490920 · Received March 7, 2012

    Report

    Report Number
    1218950-2012-00806
    Event Type
    Malfunction
    Date Received
    March 7, 2012
    Report Date
    February 13, 2012
    Manufacturer
    PHILIPS MEDICAL SYSTEMS-DUP
    Product Code
    MKJ
    PMA / PMN Number
    K031187
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NL
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE CUSTOMER REPORTED, THE DEVICE IS INTERMITTENTLY CHARGING. THERE WAS NO REPORT OF PT INVOLVEMENT. THE DEVICE WAS EVALUATED BY A PHILIPS FIELD SERVICE ENGINEER, BUT AND THE SYMPTOM COULD NOT BE DUPLICATED. THE DEVICE PASSED ALL TESTING AND WAS RETURNED TO SERVICE. BASED ON THE CUSTOMER'S REPORT, WE ARE CONSIDERING THIS A MALFUNCTION. WE CANNOT DETERMINE THE CAUSE, SINCE THE SYMPTOM WAS NOT DUPLICATED.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THE DEVICE IS INTERMITTENTLY CHARGING. THERE WAS NO REPORT OF PT INVOLVEMENT.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1