BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HEARTSTART MRX

    MDR report key: 3082944 · Received April 23, 2013

    Report

    Report Number
    1218950-2013-01454
    Event Type
    Injury
    Date Received
    April 23, 2013
    Report Date
    April 18, 2013
    Manufacturer
    PHILIPS MEDICAL SYSTEMS
    Product Code
    MKJ
    PMA / PMN Number
    K031187
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). A FOLLOW UP REPORT WILL BE SUBMITTED UPON COMPLETION OF THE INVESTIGATION.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED A DELAY IN THE ACQUISITION OF THE PADS ECG WAVEFORM DURING A CARDIAC ARREST. THIS SYMPTOM COULD IMPACT THERAPY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    174370 HEARTSTART MRX MKJ PHILIPS MEDICAL SYSTEMS M3535A 7.00.01

    Patients

    Seq Age Sex Outcome Treatment
    1