BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HEART START XL

    MDR report key: 3100028 · Received April 26, 2013

    Report

    Report Number
    1218950-2013-01457
    Event Type
    Malfunction
    Date Received
    April 26, 2013
    Report Date
    March 27, 2013
    Manufacturer
    PHILIPS MEDICAL SYSTEMS
    Product Code
    MKJ
    PMA / PMN Number
    K001725
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE DEVICE WAS EVALUATED BY A PHILLIPS FIELD SERVICE ENGINEER. THE CAUSE OF THE ISSUE WAS LOCALIZED TO A FAILURE OF THE BEZEL ASSEMBLY. THE BEZEL ASSEMBLY WAS REPLACED TO RESOLVE THE ISSUE. THE DEVICE PASSED ALL TESTING AND WAS PLACED BACK INTO SERVICE.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT THE KEYS LOSE CONTROL. THERE WAS NO REPORTED PATIENT INVOLVEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    182187 HEART START XL MKJ PHILIPS MEDICAL SYSTEMS M4735A

    Patients

    Seq Age Sex Outcome Treatment
    1