BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HEART START XL

    MDR report key: 3182335 · Received June 10, 2013

    Report

    Report Number
    1218950-2013-02261
    Event Type
    Malfunction
    Date Received
    June 10, 2013
    Report Date
    May 15, 2013
    Manufacturer
    PHILIPS MEDICAL SYSTEMS
    Product Code
    MKJ
    PMA / PMN Number
    K001725
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    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' WHEN POWERED UP. THERE WAS NO REPORTED PT INVOLVEMENT. THE 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
    261750 HEART START XL MKJ PHILIPS MEDICAL SYSTEMS M4735A

    Patients

    Seq Age Sex Outcome Treatment
    1