BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HEARTSTART MRX

    MDR report key: 1873457 · Received October 14, 2010

    Report

    Report Number
    1218950-2010-01961
    Event Type
    Malfunction
    Date Received
    October 14, 2010
    Report Date
    September 20, 2010
    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 THEY COULD NOT ACQUIRE ECG WAVEFORMS VIA PADS. THE CUSTOMER SWITCHED TO ANOTHER DEVICE AND THERE WAS NO PATIENT IMPACT. THIS COMPLAINT IS STILL BEING INVESTIGATED. A FOLLOW-UP REPORT WILL BE SUBMITTED UPON COMPLETION OF THE INVESTIGATION.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THEY COULD NOT ACQUIRE ECG WAVEFORMS VIA PADS. THE CUSTOMER SWITCHED TO ANOTHER DEVICE AND THERE WAS NO PATIENT IMPACT.

    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