BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HEARTSTART MRX -EMS DEFIBRILLATOR

    MDR report key: 6380157 · Received March 6, 2017

    Report

    Report Number
    1218950-2017-01505
    Event Type
    Malfunction
    Date Received
    March 6, 2017
    Report Date
    February 8, 2017
    Manufacturer
    PHILIPS MEDICAL SYSTEMS
    Product Code
    MKJ
    UDI-DI
    00884838006652
    PMA / PMN Number
    K031187
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    A FOLLOW UP REPORT WILL BE SUBMITTED ONCE THE INVESTIGATION IS COMPLETE.

    Description of Event or Problem · 1

    THE CUSTOMER CONTACTED PHILIPS HEALTHCARE TO REPORT THAT THE MONITORING PORT CONNECTOR PIN HOLES ARE DISFIGURED AND SPO2 PORT CONNECTOR WEAR AND DISCOLORATION. IT WAS REPORTED THAT THE ALLEGED FAILURE WAS OBSERVED WHILE IN USE ON A PATIENT. NO ADVERSE PATIENT IMPACT WAS REPORTED TO PHILIPS.

    Description of Event or Problem · 1

    THE CUSTOMER CONTACTED PHILIPS HEALTHCARE TO REPORT AN ECG CABLE FAILURES INOP. IT WAS REPORTED THAT THE ALLEGED FAILURE WAS OBSERVED WHILE IN USE ON A PATIENT. NO ADVERSE PATIENT IMPACT WAS REPORTED TO PHILIPS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    164304 HEARTSTART MRX -EMS DEFIBRILLATOR DEFIBRILLATOR MKJ PHILIPS MEDICAL SYSTEMS M3536A 00884838006652

    Patients

    Seq Age Sex Outcome Treatment
    1