BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HEART START XL

    MDR report key: 8708655 · Received June 18, 2019

    Report

    Report Number
    1218950-2019-04291
    Event Type
    Malfunction
    Date Received
    June 18, 2019
    Report Date
    October 25, 2017
    Manufacturer
    PHILIPS MEDICAL SYSTEMS
    Product Code
    MKJ
    PMA / PMN Number
    K001725
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED BY THE FIELD SERVICE ENGINEER (FSE) DURING SERVICING THAT THE THERAPY KNOB WAS FOUND TO BE DEFECTIVE. THERE IS NO PATIENT INVOLVEMENT. THIS REPORT WAS GENERATED PURSUANT TO QUALITY PLAN LC2236 - QUALITY PLAN ¿ ECR ALS SERVICE RECORD REMEDIATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    503799 HEART START XL DEFIBRILLATOR MKJ PHILIPS MEDICAL SYSTEMS M4735A

    Patients

    Seq Age Sex Outcome Treatment
    1