BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HEARTSTART MRX

    MDR report key: 2851485 · Received October 31, 2012

    Report

    Report Number
    1218950-2012-03649
    Event Type
    Malfunction
    Date Received
    October 31, 2012
    Report Date
    October 10, 2012
    Manufacturer
    PHILIPS MEDICAL SYSTEMS
    Product Code
    MKJ
    PMA / PMN Number
    K031187
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4): THE CUSTOMER REPORT THAT DURING OPCHECK THE DEVICE REBOOTED. THERE WAS NO PATIENT INVOLVEMENT. PHILIPS EVALUATED THE DEVICE AND CONFIRMED THE DEVICE REBOOTED WHEN CHARGE BUTTON WAS PRESSED DURING OPCHECK. THE PROCESSOR PCA WAS REPLACED TO RESOLVE THIS ISSUE. THE DEVICE WAS RETURNED TO THE CUSTOMER SITE AFTER PASSING ALL REQUIRED TESTING.

    Description of Event or Problem · 1

    THE CUSTOMER REPORT THAT DURING OPCHECK THE DEVICE REBOOTED. THERE WAS NO PATIENT INVOLVEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HEARTSTART MRX MKJ PHILIPS MEDICAL SYSTEMS M3535A

    Patients

    Seq Age Sex Outcome Treatment
    1