BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HEARTSTART XL

    MDR report key: 2922939 · Received November 27, 2012

    Report

    Report Number
    1218950-2012-03869
    Event Type
    Malfunction
    Date Received
    November 27, 2012
    Report Date
    October 21, 2012
    Manufacturer
    PHILIPS MEDICAL SYSTEMS
    Product Code
    MKJ
    PMA / PMN Number
    K001725
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TW
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4): THE CUSTOMER REPORTED THAT WHILE CONNECTING THE SYNCHRONOUS SIGNAL OF THE MONITOR, THE CONNECTION FAILED. THERE WAS NO PATIENT INVOLVEMENT WITH THIS ISSUE. THIS COMPLAINT IS STILL BEING INVESTIGATED. A FOLLOW-UP REPORT WILL BE SUBMITTED UPON COMPLETION OF THE INVESTIGATION.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT WHILE CONNECTING THE SYNCHRONOUS SIGNAL OF THE MONITOR, THE CONNECTION FAILED. THERE WAS NO PATIENT INVOLVEMENT WITH THIS ISSUE.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1