BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HEART START XL

    MDR report key: 3182337 · Received June 10, 2013

    Report

    Report Number
    1218950-2013-02259
    Event Type
    Malfunction
    Date Received
    June 10, 2013
    Report Date
    May 17, 2013
    Manufacturer
    PHILIPS MEDICAL SYSTEMS
    Product Code
    MKJ
    PMA / PMN Number
    K001725
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). A F/U REPORT WILL BE SUBMITTED UPON COMPLETION OF THE INVESTIGATION.

    Description of Event or Problem · 1

    THE DEVICE IS GIVING AN ERROR '10003'. THERE WAS NO REPORTED PT INVOLVEMENT ERROR CODE 10003 (DEFIB TIMEOUT) IS ACCOMPANIED BY THE SYSTEM FAILURE CYCLE POWER MESSAGE/INSTRUCTION AND THE DEVICE THEN HALTS OPERATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    261765 HEART START XL MKJ PHILIPS MEDICAL SYSTEMS M4735A

    Patients

    Seq Age Sex Outcome Treatment
    1