BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HEARTSTART MRX

    MDR report key: 2132420 · Received June 14, 2011

    Report

    Report Number
    1218950-2011-01677
    Event Type
    Malfunction
    Date Received
    June 14, 2011
    Report Date
    May 17, 2011
    Manufacturer
    PHILIPS HEALTHCARE
    Product Code
    MKJ
    PMA / PMN Number
    K031187
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE CUSTOMER REPORTED THE PADS/CPR METER CABLE CAUSED THE DEVICE TO FAIL THE USER INITIATED OPERATIONAL CHECK. THE INDIVIDUAL TEST FAILURE WAS NOT SPECIFIED. THIS IS A REPORTED TESTING ONLY FAILURE. THERE WAS NO PATIENT INVOLVEMENT. PHILIPS SENT THE CUSTOMER A REPLACEMENT PADS/CPR CABLE TO RESOLVE THIS ISSUE.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THE PADS/CPR METER CABLE CAUSED THE DEVICE TO FAIL THE USER INITIATED OPERATIONAL CHECK. THE INDIVIDUAL TEST FAILURE WAS NOT SPECIFIED. THIS IS A REPORTED TESTING ONLY FAILURE. THERE WAS NO PATIENT INVOLVEMENT.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1