BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HEARTSTART MRX

    MDR report key: 1811101 · Received August 12, 2010

    Report

    Report Number
    1218950-2010-01307
    Event Type
    Malfunction
    Date Received
    August 12, 2010
    Report Date
    July 13, 2010
    Manufacturer
    PHILIPS HEALTHCARE
    Product Code
    MKJ
    PMA / PMN Number
    K031187
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OK, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4): THE CUSTOMER REPORTED THAT THE DEVICE LOCKED UP DURING OP CHECK. THERE WAS NO REPORT OF PATIENT INVOLVEMENT. THE DEVICE WAS EVALUATED AT PHILIPS, AND THE REPORTED SYMPTOM WAS DUPLICATED. REPLACEMENT OF THE PROCESSOR PCA AND SOFTWARE RESOLVED THE ISSUE. BECAUSE MULTIPLE PARTS WERE REPLACED, WE CANNOT DETERMINE CONCLUSIVELY WHICH ONE RESOLVED THE ISSUE.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT THE DEVICE LOCKED UP DURING OP CHECK. THERE WAS NO REPORT OF 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