BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HEARTSTART MRX -EMS DEFIBRILLATOR

    MDR report key: 12432164 · Received September 7, 2021

    Report

    Report Number
    3030677-2021-14133
    Event Type
    Malfunction
    Date Received
    September 7, 2021
    Date of Event
    August 16, 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

    Description of Event or Problem · 0

    IT WAS REPORTED TO PHILIPS THAT THE DEVICE HAS AN ECG BIAS ISSUE. THE FIELD SERVICE ENGINEER (FSE) EVALUATED THE DEVICE AND FOUND THAT THE PROCESSOR PCA NEEDED TO BE REPLACED. DIAGNOSTIC PERFORMED BY ENGINEER : DIAGNOSIS BY CUSTOMER CONFIRMED BY ENGINEER. PROBLEM DESCRIPTION BY ENGINEER : CUSTOMER FUNCTION/ROLE: CUSTOMER DEVICE USE: RESUSCITATION. EXPECTED AND UNEXPECTED RESULTS: PROCESSOR BOARD- ECG BIAS. USER IMPACT: CUSTOMER REQUEST ONSITE SERVICE. PATIENT IMPACT: NO IMPACT. CURRENT SOFTWARE VERSION: N/A. TOOLS & EQUIPMENT : DEFIBRILLATOR ANALYZER,2021-12-31 00:00:00; TORQUE SCREWDRIVER,2021-12-31 00:00:00; TEST SIMULATOR KIT,2022-01-31 00:00:00; TEST SIMULATOR KIT,2022-01-31 00:00:00; ELECTRICAL SAFETY TESTER,2021-12-31 00:00:00; PARTS CONSUMED : 1.00000,453563478461,RESTORED PROCESSOR BOARD PCA. UPON CONCLUSION OF THE EVALUATION, IT WAS DETERMINED THAT THE PROCESSOR PCA REQUIRES REPLACEMENT. IT WAS REPLACED. THE DEVICE PASSED TESTING AND WAS PUT BACK INTO SERVICE.

    Description of Event or Problem · 1

    IT WAS REPORTED TO PHILIPS THAT THE DEVICE HAS AN ECG BIAS ISSUE. THERE WAS NO PATIENT INVOLVEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1331921 HEARTSTART MRX -EMS DEFIBRILLATOR DEFIBRILLATOR MKJ PHILIPS NORTH AMERICA LLC M3536A 00884838006652

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown