BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HEARTSTART MRX

    MDR report key: 2132421 · Received June 14, 2011

    Report

    Report Number
    1218950-2011-01678
    Event Type
    Malfunction
    Date Received
    June 14, 2011
    Report Date
    May 18, 2011
    Manufacturer
    PHILIPS HEALTHCARE
    Product Code
    MKJ
    PMA / PMN Number
    K031187
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THIS CUSTOMER REPORTED THAT WHILE EVALUATING AN NBP ISSUE ON THE DEVICE, THE DEVICE WOULD NOT POWER ON INTO THE MONITOR MODE AS EXPECTED. THERE WAS NO PATIENT INVOLVEMENT. THE DEVICE WAS EVALUATED LOCALLY BY PHILIPS. RELOADING THE DEVICE SOFTWARE RESOLVED THE SYMPTOM.

    Description of Event or Problem · 1

    THIS CUSTOMER REPORTED THAT WHILE EVALUATING AN NBP ISSUE ON THE DEVICE, THE DEVICE WOULD NOT POWER ON INTO THE MONITOR MODE AS EXPECTED. THERE WAS NO PATIENT INVOLVEMENT.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1