BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HEARTSTART FRX

    MDR report key: 2033585 · Received February 11, 2011

    Report

    Report Number
    3030677-2011-00011
    Event Type
    Malfunction
    Date Received
    February 11, 2011
    Report Date
    January 27, 2011
    Manufacturer
    PHILIPS MEDICAL SYSTEMS (HTST)
    Product Code
    MKJ
    PMA / PMN Number
    050004
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). FOLLOW-UP REQUIRED, PENDING EVALUATION OF THE DEVICE.

    Description of Event or Problem · 1

    CUSTOMER REPORTED THAT THEIR DEVICE IS GETTING HOT AND THE CASING IS STARTING TO MELT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HEARTSTART FRX MKJ PHILIPS MEDICAL SYSTEMS (HTST) 861304

    Patients

    Seq Age Sex Outcome Treatment
    1