BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HEARTSTART 4000

    MDR report key: 2941814 · Received December 21, 2012

    Report

    Report Number
    1218950-2012-04214
    Event Type
    Malfunction
    Date Received
    December 21, 2012
    Report Date
    November 29, 2012
    Manufacturer
    PHILIPS MEDICAL SYSTEMS
    Product Code
    MKJ
    PMA / PMN Number
    K992543
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE CUSTOMER REPORTED THAT THE DEVICE DOES NOT TURN ON. NO PATIENT INVOLVEMENT WAS REPORTED. THIS COMPLAINT IS STILL BEING INVESTIGATED. A FOLLOW-UP REPORT WILL BE SUBMITTED UPON COMPLETION OF THE INVESTIGATION.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT THE DEVICE DOES NOT TURN ON. NO PATIENT INVOLVEMENT WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HEARTSTART 4000 MKJ PHILIPS MEDICAL SYSTEMS M5500B

    Patients

    Seq Age Sex Outcome Treatment
    1