BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HEARTSTART MRX

    MDR report key: 1014022 · Received March 14, 2008

    Report

    Report Number
    1218950-2008-00162
    Event Type
    Malfunction
    Date Received
    March 14, 2008
    Report Date
    February 19, 2008
    Manufacturer
    PHILIPS MEDICAL SYSTEMS
    Product Code
    LDD
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    LA, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    THE FACTORY HAS NOT YET RECEIVED THE DEVICE FOR EVAL, AND THIS COMPLAINT IS STILL UNDER INVESTIGATION.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT DURING PREVENTIVE MAINTENANCE, THE DEVICE UNEXPECTEDLY SHUT DOWN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HEARTSTART MRX DEFIBRILLATOR LDD PHILIPS MEDICAL SYSTEMS M3535A

    Patients

    Seq Age Sex Outcome Treatment
    1