BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HEARTSTART MRX

    MDR report key: 8709593 · Received June 18, 2019

    Report

    Report Number
    1218950-2019-04319
    Event Type
    Malfunction
    Date Received
    June 18, 2019
    Report Date
    October 10, 2017
    Manufacturer
    PHILIPS MEDICAL SYSTEMS
    Product Code
    MKJ
    PMA / PMN Number
    K031187
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THE DEVICE WAS DROPPED AND REQUESTED TO RETURN THE DEVICE TO THE BENCH FOR EVALUATION. THERE IS NO PATIENT INVOLVEMENT. THIS REPORT WAS GENERATED PURSUANT TO QUALITY PLAN (B)(4) - QUALITY PLAN ¿ ECR ALS SERVICE RECORD REMEDIATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    503952 HEARTSTART MRX DEFIBRILLATOR MKJ PHILIPS MEDICAL SYSTEMS M3535A

    Patients

    Seq Age Sex Outcome Treatment
    1