BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HEARTSTART XL

    MDR report key: 2490921 · Received March 7, 2012

    Report

    Report Number
    1218950-2012-00807
    Event Type
    Malfunction
    Date Received
    March 7, 2012
    Report Date
    February 13, 2012
    Manufacturer
    PHILIPS MEDICAL SYSTEMS-DUP
    Product Code
    MKJ
    PMA / PMN Number
    K001725
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NZ
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE CUSTOMER REPORTED, THE DEVICE DOESN'T SWITCH ON. THERE WAS NO REPORT OF PT INVOLVEMENT. THE CUSTOMER ISOLATED THE ISSUE TO A FAILED AC POWER SUPPLY. PHILIPS SENT THE CUSTOMER A NEW AC POWER SUPPLY TO RESOLVE THE ISSUE.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THE DEVICE DOESN'T SWITCH ON. THERE WAS NO REPORT OF PT INVOLVEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HEARTSTART XL MKJ PHILIPS MEDICAL SYSTEMS-DUP M4735A

    Patients

    Seq Age Sex Outcome Treatment
    1