BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HEART START XL

    MDR report key: 2524777 · Received March 29, 2012

    Report

    Report Number
    1218950-2012-01075
    Event Type
    Malfunction
    Date Received
    March 29, 2012
    Report Date
    March 7, 2012
    Manufacturer
    PHILIPS MEDICAL SYSTEMS-DUP
    Product Code
    MKJ
    PMA / PMN Number
    K001725
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE CUSTOMER REPORTED A FAILURE TO DISCHARGE DURING A PT EVENT. THE USERS SWITCHED TO A DIFFERENT DEFIB TO DELIVER TREATMENT. THERE WAS NO REPORT OF NEGATIVE PT IMPACT. THERE WERE NO ECG STRIPS SAVED FROM THIS EVENT. THE HOSPITAL BIOMEDICAL ENGINEER EVALUATED THE DEVICE AND THE REPORTED SYMPTOM COULD NOT BE REPRODUCED. THE DEVICE PASSED ALL TESTING. THE PHILIPS FIELD SERVICE ENGINEER EVALUATED THE DEVICE AND COULDN'T REPRODUCE THE REPORTED SYMPTOM. THE DEVICE PASSED ALL TESTING. WE ARE UNABLE TO DETERMINE THE CAUSE OF THE REPORTED SYMPTOM.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED A FAILURE TO DISCHARGE DURING A PT EVENT. THE USERS SWITCHED TO A DIFFERENT DEFIB TO DELIVER TREATMENT. THERE WAS NO REPORT OF NEGATIVE PT IMPACT.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1