BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HEART START XL

    MDR report key: 3060702 · Received March 26, 2013

    Report

    Report Number
    1218950-2013-01044
    Event Type
    Malfunction
    Date Received
    March 26, 2013
    Report Date
    March 1, 2013
    Manufacturer
    PHILIPS MEDICAL SYSTEMS
    Product Code
    MKJ
    PMA / PMN Number
    K001725
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4): THE CUSTOMER REPORTED THE PACER FUNCTION NOT WORKING. THERE WAS NO PT INVOLVEMENT. THE DEVICE WAS SENT TO THE PHILIPS BENCH FOR EVAL. THE REPORTED SYMPTOM WAS CONFIRMED. THE ISSUE WAS LOCALIZED TO THE PACER KEYPAD. THE PACER KEYPAD WAS REPLACED TO RESOLVE THE ISSUE. THE DEVICE THEN PASSED ALL REQUIRED TESTING AND WAS RETURNED TO THE CUSTOMER SITE FOR USE. THE MALFUNCTION OF THE PACER KEYPAD CASED THE MALFUNCTION. REPLACEMENT OF THE KEYPAD RESOLVED THE ISSUE.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THE PACER FUNCTION NOT WORKING. THERE WAS NO PT INVOLVEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    123138 HEART START XL MKJ PHILIPS MEDICAL SYSTEMS M4735A

    Patients

    Seq Age Sex Outcome Treatment
    1