BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HEARTSTART MRX

    MDR report key: 8710340 · Received June 18, 2019

    Report

    Report Number
    1218950-2019-04367
    Event Type
    Malfunction
    Date Received
    June 18, 2019
    Report Date
    January 9, 2017
    Manufacturer
    PHILIPS MEDICAL SYSTEMS
    Product Code
    MKJ
    PMA / PMN Number
    K031187
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED TO PHILIPS THAT THE DEVICE WOULD NOT CLEAR THE "BATTERY CALIBRATION NEEDED" MESSAGE. THERE WAS NO REPORTED PATIENT INVOLVEMENT/ADVERSE PATIENT IMPACT. 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
    503753 HEARTSTART MRX DEFIBRILLATOR MKJ PHILIPS MEDICAL SYSTEMS M3535A

    Patients

    Seq Age Sex Outcome Treatment
    1