BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HEARTSTART MRX - EMS DEFIBRILLATOR

    MDR report key: 2050516 · Received April 5, 2011

    Report

    Report Number
    1218950-2011-00900
    Event Type
    Malfunction
    Date Received
    April 5, 2011
    Report Date
    March 8, 2011
    Manufacturer
    PHILIPS HEALTHCARE
    Product Code
    MKJ
    PMA / PMN Number
    K031187
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4): THE CUSTOMER REPORTED 12-LEAD ECG SIGNAL LOSS WHICH, IF USED FOR 12-LEAD DIAGNOSIS, COULD DELAY DIAGNOSIS OR TREATMENT. THERE WAS NO REPORT OF NEGATIVE PATIENT IMPACT. THIS COMPLAINT IS STILL BE INVESTIGATED. A FOLLOW-UP REPORT WILL BE SUBMITTED UPON COMPLETION OF THE INVESTIGATION.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED 12-LEAD ECG SIGNAL LOSS WHICH, IF USED FOR 12-LEAD DIAGNOSIS, COULD DELAY DIAGNOSIS OR TREATMENT. THERE WAS NO REPORT OF NEGATIVE PATIENT 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 82 YR