BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HEARTSTART MRX -EMS DEFIBRILLATOR

    MDR report key: 11970999 · Received June 9, 2021

    Report

    Report Number
    3030677-2021-12097
    Event Type
    Malfunction
    Date Received
    June 9, 2021
    Date of Event
    May 17, 2021
    Manufacturer
    PHILIPS NORTH AMERICA LLC
    Product Code
    MKJ
    UDI-DI
    00884838006652
    PMA / PMN Number
    K031187
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE CUSTOMER REQUESTED THAT AN AUTHORIZED FIELD SERVICE ENGINEER (FSE) BE DISPATCHED TO THE CUSTOMER SITE. UPON EVALUATION OF THE DEVICE, THE REPORTED ISSUE WAS CONFIRMED AND THE CAUSE WAS TRACED TO A FAULTY BATTERY PCA. THE BATTERY PCA WAS REPLACED AND THE DEVICE PASSED ALL TESTING. THE DEVICE REMAINS AT THE CUSTOMER SITE. THERE IS NO INDICATION OF A SYSTEMIC PROBLEM. NO FURTHER INVESTIGATION OR ACTION IS WARRANTED.

    Description of Event or Problem · 0

    IT WAS REPORTED TO PHILIPS THAT THE BATTERY PCA HAS BENT PINS. THERE WAS NO PATIENT INVOLVEMENT.

    Description of Event or Problem · 1

    IT WAS REPORTED TO PHILIPS THAT THE BATTERY PCA HAS BENT PINS. THERE WAS NO PATIENT INVOLVEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    866976 HEARTSTART MRX -EMS DEFIBRILLATOR DEFIBRILLATOR MKJ PHILIPS NORTH AMERICA LLC M3536A 00884838006652

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown