BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HEART START XL

    MDR report key: 1881551 · Received October 19, 2010

    Report

    Report Number
    1218950-2010-01983
    Event Type
    Malfunction
    Date Received
    October 19, 2010
    Report Date
    August 24, 2010
    Manufacturer
    PHILIPS HEALTHCARE
    Product Code
    MKJ
    PMA / PMN Number
    K001725
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SF
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4): THE CUSTOMER REPORTED THAT THE DEVICE DISPLAYED ECG FAULT, ERROR CODE 20004 AND CYCLE POWER. THERE WAS NO REPORT OF PATIENT IMPACT. THE DEVICE WAS EVALUATED LOCALLY WHERE THE CONDITION WAS CONFIRMED AND RESOLVED BY REPLACEMENT OF THE CONTROL PCA.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT THE DEVICE DISPLAYED ECG FAULT, ERROR CODE 20004 AND CYCLE POWER. THERE WAS NO REPORT OF PT IMPACT.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1