BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HEARTSTART MRX -EMS DEFIBRILLATOR

    MDR report key: 8708668 · Received June 18, 2019

    Report

    Report Number
    1218950-2019-04295
    Event Type
    Malfunction
    Date Received
    June 18, 2019
    Report Date
    April 4, 2017
    Manufacturer
    PHILIPS MEDICAL SYSTEMS
    Product Code
    MKJ
    PMA / PMN Number
    K031187
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    DURING SERVICING OF THE DEVICE, IT WAS NOTICED THAT THE BATTERY PCA WAS ONLY RECOGNIZING ONE OF THE TWO BATTERIES. 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
    503785 HEARTSTART MRX -EMS DEFIBRILLATOR DEFIBRILLATOR MKJ PHILIPS MEDICAL SYSTEMS M3536A

    Patients

    Seq Age Sex Outcome Treatment
    1