BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HEARTSTART XL

    MDR report key: 3063435 · Received March 28, 2013

    Report

    Report Number
    1218950-2013-01136
    Event Type
    Malfunction
    Date Received
    March 28, 2013
    Report Date
    November 1, 2012
    Manufacturer
    PHILIPS MEDICAL SYSTEMS
    Product Code
    MKJ
    PMA / PMN Number
    K001725
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4): THE CUSTOMER REPORTED AN UNSPECIFIED ECG FAILURE. THE ISSUE WAS CLARIFIED TO BE AN ERROR 20004 WHICH INDICATES A PADS ECG FAILURE. THERE WAS NO PATIENT INVOLVEMENT. THE DEVICE WAS EVALUATED BY BOTH THE CUSTOMER AND A PHILIPS FSE. AN ERROR 20004 WAS NOTED IN THE DEVICE LOG. THE CONTROL PCA AND RIBBON CABLE WERE REPLACED TO RESOLVE THE ISSUE. THE DEVICE THEN PASSED ALL REQUIRED TESTING. WE ARE UNABLE TO DETERMINE THE CAUSE OF THE ISSUE AS THE REPORTED SYMPTOM COULD NOT BE REPRODUCED.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED AN UNSPECIFIED ECG FAILURE. THE ISSUE WAS CLARIFIED TO BE AN ERROR 20004 WHICH INDICATES A PADS ECG FAILURE. THERE WAS NO PATIENT INVOLVEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    129201 HEARTSTART XL MKJ PHILIPS MEDICAL SYSTEMS M4735A

    Patients

    Seq Age Sex Outcome Treatment
    1