BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HEARTSTART MRX -EMS DEFIBRILLATOR

    MDR report key: 11747035 · Received April 29, 2021

    Report

    Report Number
    3030677-2021-11254
    Event Type
    Malfunction
    Date Received
    April 29, 2021
    Date of Event
    April 7, 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
    OK, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE DEVICE WAS RECEIVED BY BENCH REPAIR ON 16-APRIL-2021. THE NOTED FAILURE WAS IDENTIFIED DURING INSPECTION OF THE DEVICE BY AN AUTHORIZED BENCH TECHNICIAN. AS A RESULT OF THE ISSUE, IT WAS DETERMINED THAT THE BATTERY PCA WOULD NEED TO BE REPLACED. THE BENCH CONFIRMED THAT THE DEFIBRILLATOR CAP WAS OUT OF SPEC AND WOULD NEE TO BE REPLACED. UPON CONCLUSION OF THE EVALUATION, IT WAS DETERMINED THAT THIS WAS A MALFUNCTION OF THE BATTERY PCA AND DEFIBRILLATOR CAP. THE BATTERY PCA AND DEFIBRILLATOR CAP WAS REPLACED TO RESOLVE THE REPORTED ISSUE AND THE DEVICE WAS SCHEDULED TO BE RETURNED TO THE CUSTOMER SITE. NO FURTHER EVALUATION IS REQUIRED AT THIS TIME.

    Description of Event or Problem · 1

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

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    641607 HEARTSTART MRX -EMS DEFIBRILLATOR DEFIBRILLATOR MKJ PHILIPS NORTH AMERICA LLC M3536A 00884838006652

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown