BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HEARTSTART MRX - EMS DEFIBRILLATOR

    MDR report key: 2911168 · Received December 10, 2012

    Report

    Report Number
    1218950-2012-04037
    Event Type
    Malfunction
    Date Received
    December 10, 2012
    Report Date
    November 25, 2012
    Manufacturer
    PHILIPS MEDICAL SYSTEMS
    Product Code
    MKJ
    PMA / PMN Number
    K031187
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). ON (B)(6) 2012, THE CUSTOMER REPORTED HAVING A BATTERY ISSUE ON THE MRX. THIS ISSUE WAS DETECTED UPON INSTALLATION OF DEVICE. THERE WAS NO REPORT OF PT INVOLVEMENT. THE COMPLAINT IS STILL BEING INVESTIGATED. A FOLLOW-UP REPORT WILL BE SUBMITTED UPON COMPLETION OF THE INVESTIGATION.

    Description of Event or Problem · 1

    ON (B)(6) 2012, THE CUSTOMER REPORTED HAVING A BATTERY ISSUE ON THE MRX. THIS ISSUE WAS DETECTED UPON INSTALLATION OF DEVICE. THERE WAS NO REPORT OF 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