BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HEARTSTART MRX -EMS DEFIBRILLATOR

    MDR report key: 8708736 · Received June 18, 2019

    Report

    Report Number
    1218950-2019-04303
    Event Type
    Malfunction
    Date Received
    June 18, 2019
    Report Date
    June 20, 2017
    Manufacturer
    PHILIPS MEDICAL SYSTEMS
    Product Code
    MKJ
    PMA / PMN Number
    K031187
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SD, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    WHILE PERFORMING BENCH SERVICE FOR THE DEVICE, A PHILIPS BENCH TECHNICIAN IDENTIFIED THAT THE UNIT WAS EXPERIENCING AN ETCO2 HARDWARE ISSUE. 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
    503810 HEARTSTART MRX -EMS DEFIBRILLATOR DEFIBRILLATOR MKJ PHILIPS MEDICAL SYSTEMS M3536A

    Patients

    Seq Age Sex Outcome Treatment
    1