BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HEARTSTART XL

    MDR report key: 3060625 · Received March 27, 2013

    Report

    Report Number
    1218950-2013-01073
    Event Type
    Malfunction
    Date Received
    March 27, 2013
    Report Date
    March 5, 2013
    Manufacturer
    PHILIPS MEDICAL SYSTEMS
    Product Code
    MKJ
    PMA / PMN Number
    K001725
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE CUSTOMER REPORTED THAT THEY WERE UNABLE TO OBTAIN R WAVE MARKERS DURING A SYNC CARDIOVERSION PROCEDURE. THERE WAS NO NEGATIVE PT IMPACT AS TREATMENT WAS DELAYED BUT SUCCESSFUL. THE HOSPITAL BIOMED EVALUATED THE DEVICE. THE SYMPTOM WAS NOT DUPLICATED. THERE WERE NO ERROR MESSAGES IN THE LOGS. REVIEW OF THE STRIPS BY BIOMED SHOWS THE AMPLITUDE OF THE ECG LOW. THE DEVICE WAS SYNC'D OUT TO A NON-PHILIPS MONITOR FOR ECG MONITORING AND PADS WERE USED AS AN ECG SOURCE. THE HSXL INSTRUCTIONS FOR USE ADVISES THE USERS TO SELECT AN ECG LEAD THAT PROVIDES THE CLEAREST SIGNAL AND THE LARGEST QRS COMPLEX. THE DEVICE PASSED ALL TESTING AND REMAINS IN SERVICE. THERE IS NO REQUEST FOR A RESPONSE BY THE CUSTOMER. PHILIPS IS CONSIDERING THIS A MALFUNCTION BASED ON THE CUSTOMER'S DESCRIPTION ONLY. WE ARE UNABLE TO DETERMINE THE CAUSE AS THE SYMPTOM WAS NOT DUPLICATED. NO FORMAL RESPONSE WAS REQUESTED AND NONE IN WARRANTED.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT THEY WERE UNABLE TO OBTAIN R WAVE MARKERS DURING A SYNC CARDIOVERSION PROCEDURE. THERE WAS NO NEGATIVE PT IMPACT AS TREATMENT WAS DELAYED BUT SUCCESSFUL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    124909 HEARTSTART XL MKJ PHILIPS MEDICAL SYSTEMS M4735A

    Patients

    Seq Age Sex Outcome Treatment
    1