BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HEART START XL

    MDR report key: 3043388 · Received March 11, 2013

    Report

    Report Number
    1218950-2013-00858
    Event Type
    Malfunction
    Date Received
    March 11, 2013
    Report Date
    February 13, 2013
    Manufacturer
    PHILIPS MEDICAL SYSTEMS
    Product Code
    MKJ
    PMA / PMN Number
    K001725
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4): THE CUSTOMER REPORTED THAT THE KEYPAD WAS NOT WORKING. THERE WAS NO REPORTED ADVERSE PATIENT IMPACT. THE DEVICE WAS EVALUATED BY AN AUTHORIZED SERVICE PROVIDER. THE SYMPTOM WAS CLARIFIED AS THE SOFTKEYS ON THE BEZEL WERE NOT WORKING. THE ISSUE WAS LOCALIZED TO A FAILURE OF THE BEZEL ASSEMBLY. THE CUSTOMER WAS ADVISED TO REPLACE THE BEZEL ASSEMBLY. THE DEVICE REMAINS AT THE CUSTOMER SITE. THIS WAS A MALFUNCTION OF THE BEZEL ASSEMBLY.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT THE KEYPAD WAS NOT WORKING. THERE WAS NO REPORTED ADVERSE PATIENT IMPACT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    102710 HEART START XL MKJ PHILIPS MEDICAL SYSTEMS M4735A

    Patients

    Seq Age Sex Outcome Treatment
    1