BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HEARTSTART MRX

    MDR report key: 2170832 · Received June 22, 2011

    Report

    Report Number
    1218950-2011-01796
    Event Type
    Malfunction
    Date Received
    June 22, 2011
    Report Date
    March 14, 2011
    Manufacturer
    PHILIPS HEALTHCARE - ANDOVER
    Product Code
    MKJ
    PMA / PMN Number
    K031187
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BR
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). INITIALLY THE CUSTOMER REPORTED THAT THE DEVICE WOULD NOT PASS OP CHECK. THERE WAS NO ADDITIONAL INFORMATION TO SUPPORT THAT THE DEVICE WAS LESS THAN FULLY FUNCTIONAL FOR THE DELIVERY OF THERAPY AT THAT TIME. NOTE THAT OPCHECK FAILURE ALONE DOES NOT INDICATE A DEVICE MALFUNCTION. ON (B)(6) 2011 NEW INFORMATION BECAME AVAILABLE, AND THE REPORTED SYMPTOM WAS CLARIFIED AS A FAILURE TO DELIVER ENERGY DURING OPCHECK. THIS NEW INFORMATION MAKES THIS COMPLAINT REPORTABLE. THE DEVICE WAS EVALUATED BY A THIRD PARTY SERVICE PROVIDER AND THE SYMPTOM WAS VERIFIED. REPLACING THE THERAPY PCA RESOLVED THE ISSUE.

    Description of Event or Problem · 1

    INITIALLY THE CUSTOMER REPORTED THAT THE DEVICE WOULD NOT PASS OP CHECK. THERE WAS NO ADDITIONAL INFORMATION TO SUPPORT THAT THE DEVICE WAS LESS THAN FULLY FUNCTIONAL FOR THE DELIVERY OF THERAPY AT THAT TIME. NOTE THAT OPCHECK FAILURE ALONE DOES NOT INDICATE A DEVICE MALFUNCTION. ON (B)(6) 2011 NEW INFORMATION BECAME AVAILABLE, AND THE REPORTED SYMPTOM WAS CLARIFIED AS A FAILURE TO DELIVER ENERGY DURING OPCHECK.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HEARTSTART MRX MKJ PHILIPS HEALTHCARE - ANDOVER M3535A

    Patients

    Seq Age Sex Outcome Treatment
    1