BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HEARTSTART MRX

    MDR report key: 2150370 · Received June 7, 2011

    Report

    Report Number
    1218950-2011-01596
    Event Type
    Malfunction
    Date Received
    June 7, 2011
    Report Date
    May 11, 2011
    Manufacturer
    PHILIPS HEALTHCARE
    Product Code
    MKJ
    PMA / PMN Number
    K031187
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE CUSTOMER REPORTED THAT THE BATTERY WAS LOW AND THE UNIT WOULD NOT POWER ON. THEY ALSO INDICATED THAT THE INLET WAS PULLED OUT FROM THE POWER MODULE. THERE WAS NO REPORT OF ADVERSE PATIENT IMPACT. A PHILIPS FIELD SERVICE ENGINEER RESOLVED THE REPORTED ISSUE BY REPLACING THE AC POWER MODULE.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT THE BATTERY WAS LOW AND THE UNIT WOULD NOT POWER ON. THEY ALSO INDICATED THAT THE INLET WAS PULLED OUT FROM THE POWER MODULE. THERE WAS NO REPORT OF ADVERSE PATIENT IMPACT.

    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