BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HEARTSTART MRX-EMS DEFIBRILLATOR

    MDR report key: 1841454 · Received September 15, 2010

    Report

    Report Number
    1218950-2010-01601
    Event Type
    Malfunction
    Date Received
    September 15, 2010
    Report Date
    August 16, 2010
    Manufacturer
    PHILIPS HEALTHCARE
    Product Code
    MKJ
    PMA / PMN Number
    K031187
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4): THE CUSTOMER REPORTED 12-LEAD ECG SIGNAL LOSS (ONLY DISPLAYS LEAD II) WHICH, IF USED FOR 12-LEAD DIAGNOSIS, COULD DELAY DIAGNOSIS OR TREATMENT. THERE WAS NO REPORT OF PT IMPACT. THIS COMPLAINT IS STILL BEING INVESTIGATED. A F/U REPORT WILL BE SUBMITTED UPON COMPLETION OF THE INVESTIGATION.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED 12-LEAD ECG SIGNAL LOSS (ONLY DISPLAYS LEAD II) WHICH, IF USED FOR 12-LEAD DIAGNOSIS, COULD DELAY DIAGNOSIS OR TREATMENT. THERE WAS NO REPORT OF PT IMPACT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HEARTSTART MRX-EMS DEFIBRILLATOR MKJ PHILIPS HEALTHCARE M3536A

    Patients

    Seq Age Sex Outcome Treatment
    1