BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HEARTSTART MRX

    MDR report key: 2954094 · Received February 7, 2013

    Report

    Report Number
    2954094
    Event Type
    Malfunction
    Date Received
    February 7, 2013
    Date of Event
    January 3, 2013
    Report Date
    January 22, 2013
    Manufacturer
    PHILIPS MEDICAL SYSTEMS
    Product Code
    MKJ
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    MN, US

    Narratives

    Description of Event or Problem · 1

    NON-EMERGENT CARDIOVERSION PERFORMED. DEFIB PADS PLACED ON PATIENT ANTERIOR POSTERIOR ON MRX 1 (DEFIBRILLATOR), MACHINE ON SYNC MODE RAMPED UP TO 150 JOULES BUT NO SHOCK DELIVERED. TEAM ATTEMPTED AGAIN WITH SAME PADS, SAME MRX MACHINE, AGAIN NO SHOCK DELIVERED, NO PROMPT FROM MACHINE TO INDICATE NO SHOCK DELIVERED MRX PERFORMING THE RAMP SOUND OF EEEEEEEEEE. TEAM DISCONNECTED THE PAD CABLE FROM MRX 1 AND RECONNECTED TO MRX 2, RAMPED UP JOULES TO 150 BUT SAME OUTCOME OF NO SHOCK AND NO MESSAGE FROM MACHINE. TEAM REMOVED PADS, GRABBED THE PINK LABELED PADS (OLD PACKAGING) AND PLACED PADS ANTERIOR/ POSTERIOR, RAMPED MRX2 AND SHOCK WAS DELIVERED. NO PATIENT HARM.PHILLIPS ADULT DEFIB PADS IN HOUSE HAVE 2 DIFFERENT PACKAGING. PHILLIPS CHANGED THE PACKAGING, BUT INDICATES THE PRODUCT REMAINS UNCHANGED. NEW PACKAGE IS RED, THE OLD IS PINK. NEW PACKAGING DOES APPEAR DIFFERENT IN APPLICATION INSTRUCTIONS AS IT DOES NOT SHOW ANTERIOR/POSTERIOR APPLICATION FOR ADULTS, ONLY PEDS.WHAT WAS THE ORIGINAL INTENDED PROCEDURE?CARDIOVERSION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    51443 HEARTSTART MRX AUTOMATED EXTERNAL DEFIBRILLATORS (NON-WEARABLE) MKJ PHILIPS MEDICAL SYSTEMS M3535A *
    51444 HEARTSTART ELECTRODE, ELECTRODCARDIOGRAPH, MULTI-FUNCTION MLN PHILIPS MEDICAL SYSTEMS * 090512-01

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR