BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PAD CONNECTOR CABLE

    MDR report key: 4250229 · Received November 6, 2014

    Report

    Report Number
    1218950-2014-06714
    Event Type
    Malfunction
    Date Received
    November 6, 2014
    Date of Event
    August 10, 2014
    Report Date
    October 7, 2014
    Manufacturer
    PHILIPS MEDICAL SYSTEMS
    Product Code
    MKJ
    PMA / PMN Number
    K992543
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). A CORPORATE RISK MANAGER FOR THE HOSPITAL INDICATED THAT THE DEVICE BEHAVIOR DID NOT IMPACT PATIENT OUTCOME. ECG STRIPS OR AN ELECTRONIC EVENT FILE ARE NOT AVAILABLE FOR REVIEW BY PHILIPS. THE DEVICE AND THERAPY CABLE WERE EVALUATED BY THE HOSPITAL'S CLINICAL ENGINEERING DEPARTMENT. THE REPORTED SYMPTOM WAS REPRODUCED. THE ISSUE WAS ISOLATED TO A FAULTY THERAPY CABLE. NO THAT THE CUSTOMER'S REVIEW OF THE DEVICE STATUS LOG INDICATED A THERAPY CABLE FAILURE ON (B)(6) AT 8"41 (THE TIME OF THE EVENT IS NOT KNOWN). THE CUSTOMER REPLACED THE THERAPY CABLE TO RESOLVE THE ISSUE. THE DEVICE PASSED ALL TESTING BY THE CUSTOMER AND WAS RETURNED TO USE. THE THERAPY CABLE IS NOT AVAILABLE FOR FURTHER EVALUATION BY PHILIPS. PHILIPS CONCLUDED THAT THIS REPRESENTED A FAILURE OF THE THERAPY CABLE.

    Description of Event or Problem · 1

    IT WAS REPORTED TO PHILIPS HEALTHCARE THAT THE DEVICE DID NOT RECOGNIZE THAT THERAPY CABLE WAS PLUGGED INTO THE DISPOSABLE PADS CONNECTED TO THE PATIENT. ANOTHER DEFIBRILLATOR WAS USED FOR PATIENT CARE. THE INVOLVED PATIENT EXPIRED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    714303 PAD CONNECTOR CABLE MKJ PHILIPS MEDICAL SYSTEMS M3508A

    Patients

    Seq Age Sex Outcome Treatment
    1