BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HEARTSTART XL

    MDR report key: 3040495 · Received January 31, 2013

    Report

    Report Number
    1218950-2013-00348
    Event Type
    Malfunction
    Date Received
    January 31, 2013
    Report Date
    January 11, 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 CUSTOMER REPORTED A CONTROL PANEL BUTTON WAS BROKEN. THERE WAS NO REPORT OF PT INVOLVEMENT. THE DEVICE WAS EVALUATED BY A PHILIPS FSE AND THE ISSUE WAS VERIFIED. MULTIPLE PARTS WERE FOUND TO BE DEFECTIVE. REPLACING THE MULTIPLE PARTS RESOLVED THE REPORTED ISSUE. THE DEVICE PASSED TESTING AND WAS RETURNED TO THE CUSTOMER. WE CANNOT DETERMINE THE EXACT CAUSE OF THE CUSTOMER'S REPORTED PROBLEM DUE TO MULTIPLE PARTS BEING REPLACED.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED A CONTROL PANEL BUTTON WAS BROKEN. THERE WAS NO REPORT OF PT INVOLVEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    44025 HEARTSTART XL MKJ PHILIPS MEDICAL SYSTEMS M4735A

    Patients

    Seq Age Sex Outcome Treatment
    1