BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HEARTSTART MRX -EMS DEFIBRILLATOR

    MDR report key: 2841412 · Received October 23, 2012

    Report

    Report Number
    1218950-2012-03559
    Event Type
    Malfunction
    Date Received
    October 23, 2012
    Report Date
    October 3, 2012
    Manufacturer
    PHILIPS MEDICAL SYSTEMS
    Product Code
    MKJ
    PMA / PMN Number
    K031187
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE CUSTOMER REPORTED THAT THE DEVICE WOULD NOT RECOGNIZE PADS ECG AND FAILED OPERATIONAL CHECK. THIS WAS IDENTIFIED DURING TESTING OF THE DEVICE; THERE WAS NO PT INVOLVEMENT. THE DEVICE WAS RETURNED TO PHILIPS FOR EVAL AND THE REPORTED SYMPTOM WAS REPRODUCED. THE PROBLEM WAS ISOLATED TO THE POWER PCA. REPLACEMENT OF THE POWER PCA RESOLVE THE SYMPTOM.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT THE DEVICE WOULD NOT RECOGNIZE PADS ECG AND FAILED OPERATIONAL CHECK. THIS WAS IDENTIFIED DURING TESTING OF THE DEVICE; THERE WAS NO PT INVOLVEMENT.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1