BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HEARTSTART MRX

    MDR report key: 2170853 · Received June 22, 2011

    Report

    Report Number
    1218950-2011-01791
    Event Type
    Malfunction
    Date Received
    June 22, 2011
    Report Date
    May 24, 2011
    Manufacturer
    PHILIPS HEALTHCARE - ANDOVER
    Product Code
    MKJ
    PMA / PMN Number
    K031187
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OR, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE CUSTOMER REPORTED THE UNIT HAS A BAD POWER SUPPLY. THE CUSTOMER ISOLATED THE PROBLEM, AND REQUESTED A PARTS ID FOR THE AC POWER SUPPLY. AS OF 6/14/2011 THERE HAVE BEEN NO FURTHER REPORTS FROM THE CUSTOMER REGARDING THIS ISSUE.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THE UNIT HAS A BAD POWER SUPPLY.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1